Methods of securing a fastener

ABSTRACT

Embodiments may include an attachable fastener, which may include a bondable material that may be secured to the end of an end effector. Vibration may be tuned to occur at a distal end of the fastener. Accordingly, the fastener may be used to generate heat at a distal point of contact. If the contact surface contains bondable material, that material may be softened. If the fastener includes bondable material at the point of contact, that material may also be softened by heat produced by vibration at the contact area. A hard implant or another polymeric material may function as the anvil.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/953,652, filed Jul. 29, 2013, which is: a continuation of U.S. patentapplication Ser. No. 12/202,210, filed Aug. 29, 2008, issued as U.S.Pat. No. 8,496,657, which is a non-provisional patent applicationclaiming benefit under 35 U.S.C. § 119(e) of U.S. ProvisionalApplication No. 60/968,969, filed Aug. 30, 2007; a continuation-in-partapplication of U.S. patent application Ser. No. 11/416,618 filed May 3,2006, issued as U.S. Pat. No. 7,967,820; a continuation-in-partapplication of U.S. patent application Ser. No. 11/689,670, filed Mar.22, 2007, issued as U.S. Pat. No. 9,610,073; and a continuation-in-partapplication of U.S. patent application Ser. No. 11/671,556, filed Feb.6, 2007, which claims the benefit of U.S. Provisional Applications60/765,857, filed Feb. 7, 2006; 60/784,186, filed Mar. 21, 2006; and60/810,080, filed Jun. 1, 2006. The entire contents of each of theaforementioned applications are hereby expressly incorporated byreference into this disclosure as if set forth fully herein.

FIELD

The invention relates to fixation or fastening of tissues and implantswithin the body, such as the fastening of two different tissue types,the fastening of an implant to tissue, or the fastening of an implant toanother implant. This may involve using an energy source to bond and/ormechanically interlock biocompatible materials intracorporeally tostabilize tissue within a patient's body, such as a fractured bone. Thepresent invention also relates to the use of an energy source to removean implant.

BACKGROUND

Body tissue often requires repair and stabilization following traumasuch as a fractured bone, torn ligament or tendon, ripped muscle, or theseparation of soft tissue from bone. For example, trauma to the rotatorcuff usually results in a portion, if not all, of the ligament beingtorn away from bone. To repair such an injury, the rotator cuff must berepositioned to its anatomically correct location and secured to thebone.

One method of repairing a damaged rotator cuff is through the use of abone anchor and a suture. A hole is drilled in the bone near where therotator cuff will be reattached to the bone. Then, an instrument is usedto place a mattress stitch with a suture in the detached portion of therotator cuff. The suture is slideably positioned through the anchor, andthe anchor is placed in the bone hole using an insertion instrument.This instrument includes an anvil and mandrel placed in contact with theanchor so that when the anvil and mandrel are moved in oppositedirections relative to each other, the anchor is deformed. Thedeformation locks the anchor within the bone. Thereafter, the suture istensioned drawing the rotator cuff toward the anchor. A suture lock isthen activated by the insertion instrument to thereby pinch the suturebetween the anchor and suture lock.

In another example, fractured bones are a common injury seen in traumacenters. Sports activities, vehicle accidents, industrial-typeincidents, and slip and fall cases are just a few examples of how bonesmay become fractured. Surgeons in trauma centers frequently encountermany different types of fractures with a variety of different bones.Each bone and each fracture type may require unique procedures anddevices for repairing the bone. Currently, a one-solution-fixes-alldevice is not available to repair fractured bones. Instead, surgeons mayuse a combination of bone screws, bone plates, and intramedullary rods.

Bone plates may be positioned internal to the skin, i.e. positionedagainst the fractured bone, or may be positioned external to the skinwith rods connecting the bone and plate. Conventional bone plates areparticularly well-suited to promote healing of the fracture bycompressing the fracture ends together and drawing the bone into closeapposition with other fragments and the bone plate. However, onedrawback with plates and screws is that with the dynamic loading placedon the plate, loosening of the screws and loss of stored compression canresult.

To reduce the potential of loosening, locking screws and a locking boneplate may be used. U.S. Pat. No. 5,085,660 to Lin discloses a lockingplate system. The system has multiple locking pins, each with one endformed as a screw to lock in the pending fastening bones or vertebraltubercles, with another end defining rectangular or similarly shapedlocking post having a threaded locking end. Near the locking post end,there is formed a stopping protrusion. A plate defines multiple lockingbores disposed at one side to be placed over the locking post end untilthe plate reaches the stopping protrusion on the locking pin. The platedefines multiple threaded screwing bores near the other side to receivelocking pin screw. Multiple locking devices fix the side of the platehaving locking bores to the locking post end of its locking pins.Multiple screwing pins each have one end formed as a pin to be used forpenetrating the threaded screwing bore to lock into the bone or thevertebral tubercle. Another end which forms a head is for holdingagainst the threaded screwing bore of the plate. Threads are providednear the head for the screwing pins to be screwed within the threadedscrewing bore of the plate.

An example of an external bone plate system is disclosed in U.S. Pat.No. 6,171,307 to Orlich. Orlich teaches an apparatus and procedure forthe external unilateral fracture fastening, fracture compression orenlargement of osseous tissue with a metal or equivalent materialslotted forked stick to hold and position the threaded pins in itslength, inserted in the bone with multiple fastening slidable screws andtheir bolts to attach the pins to the slotted forked stick, a solidslidable cube to hold and position the slotted forked stick, asupporting axial bar, and an axial threaded bar. A preferred embodimentincludes at least three slotted forked sticks that hold and fix, withthe use of compression screws and their bolts, threaded pins thatpenetrate the proximal and distal fragments of the bone through bothcorticals. Another preferred embodiment includes slotted forked sticksthat adapt to the threaded pins, introduced in the bone, at any degreeof inclination or orientation that these pins might have with respect tothe bone.

In addition to internal or external bone plates, surgeons sometimes useintramedullary rods to repair long bone fractures, such as fractures ofthe femur, radius, ulna, humerus, fibula, and tibia. The rod or nail isinserted into the medullary canal of the bone and affixed therein byscrews or bolts. After complete healing of the bone at the fracturesite, the rod may be removed through a hole drilled in the end of thebone. One problem associated with the use of today's intramedullary rodsis that it is often difficult to treat fractures at the end of the longbone. Fastener members, such as bolts, are positioned through thecortical bone and into threaded openings in the rod. However, the numberand positioning of the bolt/screw openings are limited at the tip of therod because of the decreased surface area of the rod and the reducedstrength at the tip of the rod. Therefore, fractured bone sections atthe distal end of a femur, for example, may not be properly fastened tothe intramedullary rod. Various inventions have been disclosed to repairtissue and fasten implants to tissue. U.S. Pat. No. 5,120,175 toArbegast et al. discloses a fastener having an elongated shank formed ofa shape memory alloy, a head at the upper end of the shank, and anannular segment at the lower end of said shank having a deformedcross-sectional shape suitable for insertion into an opening extendingthrough adjacent workpieces. The annular segment has a frusto-conicaltrained shape that is larger than this opening. The annular segmentradially flares from the deformed shape to an approximation of thetrained shape when heated above a critical transformation temperature,thereby securing the fastener in place with respect to the workpieces.Alternatively, a sleeve made of a different material (e.g. aluminum)extending over a portion or the entire length of the fastener can beadded for improved deformational characteristics, by providing the samefrusto-conical shape through axial contraction of the shank.

U.S. Pat. No. 5,290,281 to Tschakaloff teaches a surgical systemincluding a thermoplastic, body absorbable, bodily tissue fixation platehaving a plurality of formations and a plurality of through-boresarranged in alternating relation along with plate. The body absorbablefasteners are adapted for insertion into the through-bores to secure theplate to underlying bodily tissue. The heating apparatus includes a wandhaving a heating tip of a configuration adapted to substantiallymatingly cooperate with the formations to facilitate heating and bendingof the plate into conformance with the underlying bodily tissue.

U.S. Pat. No. 5,941,901 to Egan discloses an expandable soft tissuefastening assembly for use in anchoring soft tissue to bone. Theassembly includes a tab connected to an anchor, a sleeve adapted tosurround the anchor, and a flange adapted to hold a soft tissue segmentnext to a bone. The sleeve is inserted into a blind hole in a bone, anda section of soft tissue is placed over the hole next to the bone.Energy is applied to the flange while a predetermined axial tension isapplied to the tab to compress a flared portion of the anchor againstthe sleeve. An upper tube portion of the anchor and the flange arebonded together, and the applied axial force on the tab separates itfrom the anchor, leaving the assembly anchored in the bone and the softtissue section anchored in place between the flange and the bone. U.S.Pat. No. 7,018,380 to Cole discloses a femoral intramedullary rodsystem. The rod system is capable of treating a variety of femoral bonefractures using a uniform intramedullary rod design. The systemgenerally comprises an intramedullary rod defining an opening having anupper surface and a transverse member including a bone engaging portionand a connection portion defining a thru-hole with the nail sized topass therethrough. A pin is selectively coupled to the transverse memberto rigidly assemble the transverse member to the nail when the nail ispassed through the thru-hole and the pin is received within the opening.In an alternative design, an epiphyseal stabilizer is joined to the nailby a locking member.

Also, U.S. Pat. No. 6,228,086 to Wahl et al. discloses a modularintramedullary nail. The intramedullary nail apparatus comprises a nailhaving a proximal portion, a middle portion and a distal portion. Theproximal portion has a longitudinal slot adapted to receive at least onefixing element and the distal portion has at least one transverse bore.The proximal portion has a longitudinal axial bore. The apparatusfurther includes a set of inserts, each of which is adapted to beinserted in the longitudinal bore. Each insert has at least one guidingbore, the orientation and position of which is different for each of theinserts.

Another assembly and method to fasten tissue is disclosed in U.S. Pat.No. 6,056,751 to Fenton et al. Fenton teaches a soft tissue fasteningassembly comprising an anchor element which is installed in a bone orother tissue, and a joiner element which mates with the anchor elementto define a tissue capture region between them. A section of soft tissueis held within the tissue capture region, and energy is transmitted intothe joiner element to cause relative vibratory motion between therespective components and localized melting of the contacting portionsof the respective components to establish a welded joint. The softtissue segment is thus fixed to the bone without sutures or otherfasteners.

U.S. Pat. No. 6,080,161 to Eaves, I I I et al. teaches a fastener forsecuring an osteosynthesis plate to a plurality of bone segments isprovided. The fastener in the form of a fastener blank includes anelongated shank adapted for insertion through an opening in the plateand into a hole formed in the bone. The upper end of the shank forms ahead that serves to secure the plate to the bone. The elongated shank isconstructed of a material which when heated will deform to form a tightfit within the hole drilled in the bone. The fastener is preferably madeof a resorbable material. The invention also provides a method forsecuring a plate to a bone using the fasteners of the invention. Afastener blank is positioned into the hole so that a portion of theblank extends into the hole provided in the bone and another portionoverlies the plate. The blank is heated to raise the temperature of theblank above the transition temperature of the material from which it ismade and deform the blank into a tight fit within the hole.

U.S. Pat. No. 6,605,090 to Trieu et al. discloses orthopedic implantsand methods of treating bone defects. More specifically, but notexclusively, the present invention is directed to non-metallic implantsand to methods for intra-operative assembly and fastening of orthopedicimplants to facilitate medical treatment. The non-metallic implantassembly can be secured to underlying tissue by a fastener, such as abone screw, that is capable of swelling on contact with fluid in theunderlying tissue. Alternatively, the non-metallic implant assembly canbe assembled intra-operatively using a fastener that is adhesivelybonded to a bone plate or the bone plate can be deformed using heat,force or solvents to inhibit withdrawal of the fastener. In preferredembodiments, both the fastener and the bone plate are formed ofbiodegradable material.

Also, U.S. Patent Publication No. 2004/0030341 to Aeschlimann et al.teaches implants at least partially consist of a material that can beliquefied by means of mechanical energy. Particularly suitable materialsof this type are thermoplastics (e.g. resorbable thermoplastics) orthixotropic materials. The implants are brought into contact with thetissue part, are subjected to the action of vibratory energy and aresimultaneously pressed against the tissue part. The liquefiable materialthen liquefies and is pressed into openings or surface asperities of thetissue part so that, once solidified, it is positively joined thereto.The implantation involves the use of an implantation device comprising agenerator, an oscillating element and a resonator, whereby the generatorcauses the oscillating element to mechanically oscillate, and theelement transmits the oscillations to the resonator. The resonator isused to press the implant against the tissue part whereby causingoscillations to be transmitted to the implant. The implants are, forexample, pin-shaped or dowel-shaped and are used in lieu of screws forforming connections with bone tissue, whereby the bone tissue isoptionally pre-bored for positioning the implant. By virtue of the factthat it is unnecessary to transmit any torsional forces to the implants,these implants can be provided with a design that is weaker, i.e.slimmer than that of known screws made of the same material, and theycan be implanted more quickly.

Existing systems and techniques for repairing tissue, like the onespreviously described, can be complex, time consuming, lack thecharacteristic of being employed with precision, be damaging to tissue,and/or fail to provide a robust fastening of tissue. Therefore, there isa need for an apparatus and method for the fastening of tissue thatinvolves reduced technical ability, fewer medical instruments, less timeto complete, greater strength and precision, and preservation of livingtissue. There is a need for a system that involves the preciseapplication of energy to thermoplastic material to affix tissue andimplants within the body. There also exists a need to be able to removepreviously joined thermoplastic materials should the clinical situationdictate this.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention, and theattendant advantages and features thereof, will be more readilyunderstood by reference to the following detailed description whenconsidered in conjunction with the accompanying drawings wherein:

FIG. 1 is a perspective view of an exemplary vibratory bonding device;

FIGS. 2A and 2B illustrate exemplary cartridge heaters of the presentinvention;

FIGS. 3A-3K show exemplary embodiments of a bonding horn;

FIGS. 4A-4C illustrate a three-function bonding horn;

FIG. 5 shows the input parameters of a bonding control unit;

FIG. 6 illustrates a manual bonding control box;

FIG. 7 shows a control box having pre-set bonding parameters;

FIG. 8A is an illustration of another embodiment of a bonding controlunit;

FIG. 8B is an illustration of another embodiment of bonding controlunit;

FIG. 8C is a graph showing a bonding profile having varying wattage;

FIG. 9 is a flowchart showing the steps for adjusting the bondingdevice;

FIG. 10 is a diagram showing an electrical circuit for checking thebonding device;

FIGS. 11A and 11B illustrate a physical positive feedback device;

FIG. 12 shows an embodiment of a thermoplastic fastener;

FIGS. 13 and 14 illustrate the fastener of FIG. 12 fixed to a spinalcage;

FIG. 15 shows an end effector used for implant removal;

FIG. 16 shows the end effector of FIG. 15 contacted to a T handle;

FIGS. 17 and 18 show the end effector of FIG. 15 in use to remove animplant;

FIG. 19 shows a knotless suture fastening system;

FIG. 20 shows a suture secured to the knotless suture fastening systemof FIG. 19;

FIG. 21 shows a first staking application involving the joining of twoporous materials;

FIG. 22 shows a second staking application involving the fastening ofsoft tissue to bone with a polymeric anchor;

FIG. 23 shows a third staking application involving fracture fasteningwith a plate and bone screws;

FIG. 24 shows a fourth staking application involving near field stakingand far field bonding;

FIGS. 25A-25C show another staking application involving a bone screwand plate;

FIGS. 26A-26C show a staking application for a slotted plate and bonescrew;

FIGS. 27A-27C show a PEEK pin used to prevent loosening of a polyaxialpedicle screw/rod construct;

FIGS. 28A-28C show bone screws and plates that can be angulated;

FIG. 29 shows a dome shaped end effector;

FIG. 30 shows an end effector with a removal metallic pin that can beimplanted;

FIG. 31 illustrates an exemplary process for vibratory staking;

FIG. 32 illustrates a fastener and end effector of the invention,wherein the fastener is embedded within bondable material;

FIG. 32A illustrates an alternative welding horn or fastener of theinvention, with a chiseled end profile;

FIG. 33 illustrates an alternative view of the fastener and end effectorof FIG. 32;

FIG. 34 shows the fastener of FIG. 32 embedded within bondable material;

FIG. 35 illustrates a cross section through the center of a long axis ofthe fastener of FIG. 36;

FIG. 36 illustrates a fastener of the invention, engageable with thefastener of FIG. 32;

FIG. 37 illustrates the fastener of FIG. 32 embedded, with the fastenerof FIG. 36 engaged;

FIG. 38 illustrates a method of locking a position of the fastener ofFIG. 36, in accordance with the invention, within the embedded fastenerof FIG. 32;

FIG. 39 is a cross section through the center of the long axis offastener of FIG. 38, after the locking step of FIG. 38;

FIG. 39A is a cross section through the locking aperture of the fastenerof FIG. 38, after locking;

FIG. 40 illustrates an embedded fastener in accordance with FIG. 32,embedded within bondable material adjacent to an implant within thebody, taken in cross section through the center of the long axis of theimplant and embedded fastener;

FIG. 40A is an enlarged view of the embedded fastener of FIG. 40;

FIG. 41 is a cross section through the center of a long axis of a femur,illustrating an embeddable end effector of the invention;

FIG. 42 illustrates the end effector of FIG. 41, secured within thefemur;

FIG. 43 illustrates a condylar replacement implant secured at least inpart by the end effector of FIG. 41;

FIG. 44 illustrates fasteners and methods of fastening in accordancewith the invention, including far field fastening, mid-field fastening,and near field fastening;

FIG. 45 illustrates a longitudinal cross section through the center ofan end effector in accordance with the invention, and the fastener ofFIG. 45A, illustrating the relationship therebetween for forming a cap;

FIG. 45A illustrates a cross section through the center of alongitudinal axis of a fastener in accordance with the invention,adapted to secure a plate, and form a cap;

FIG. 45B illustrates the fastener of FIG. 45A, together with a plate orload spreading device to be fastened;

FIG. 45C illustrates a fastener of the invention formed of twodissimilar materials at least mechanically interlocked to each other toform the fastener;

FIG. 46 illustrates a cross section through the center of a longitudinalaxis of a femur, hip implant, and end effector of the invention;

FIG. 46A illustrates an enlarged view of a portion of FIG. 46,illustrating methods of repairing loosened bondable material within thebody;

FIG. 46B illustrates an end effector and projections of the invention,for introducing bondable material within the body;

FIG. 46C illustrates the end effector and projections of FIG. 46B,positioned within the body, illustrated in a cross section through thecenter of a longitudinal axis of a bone within the body;

FIG. 46D-H illustrates various fasteners in accordance with theinvention;

FIG. 47A illustrates a cross section through a longitudinal axis of atibial implant and tibia, illustrating the use of fasteners inaccordance with the invention;

FIG. 47B illustrates fastening in accordance with the prior art;

FIG. 47C illustrates fastening of a graft or augment in conjunction withthe tibial insert of FIG. 47A, as well as alternative fasteners andfastening methods in accordance with the invention;

FIG. 47D illustrates the use of a clamp in conjunction with fasteners inaccordance with the invention, and further illustrates the use of aspacer in accordance with the invention;

FIG. 47E illustrates the spacer of FIG. 47D, in position afterfastening, as well as a fastener securing a formerly clamped region;

FIG. 48 illustrates an end effector coated over a portion of itsexterior surface with bondable material, in accordance with theinvention;

FIG. 49 illustrates the end effector of FIG. 48, deployed within thebody in a partial longitudinal cross section through the center of theend effector and the bone, and further illustrates securing of a jointreplacement component in accordance with the invention;

FIG. 50 illustrates bonding to a roughened or porous surface, inaccordance with the invention;

FIG. 51 illustrates a fastener having two prongs, in accordance with theinvention, fastened to a roughened or porous surface, or a surfacehaving at least one cavity or projection into or upon which bondablematerial may become connected;

FIG. 51A illustrates a cross section view of the fastener shown in FIG.51;

FIG. 51B illustrates a perspective view of the fastener shown in FIG.51;

FIGS. 52A and 52B illustrate a device and method in accordance with theinvention of securing a layer using heat meltable flanges;

FIG. 53 illustrates a method of securing an implant through fasteninginto a porous or roughened surface, or a surface with a cavity orprojection, using a fastener of the invention inserted through aretrograde approach;

FIG. 53A illustrates the fastener and methods of FIG. 53, afterfastening;

FIG. 54 illustrates an implant positioned and secured within an offsetlocation using fasteners in accordance with the invention

FIG. 54A illustrates a wedge shaped fastener in accordance with theinvention;

FIG. 54B illustrates an enlarged view of a cone shaped fastenerillustrated in FIG. 54;

FIG. 54C illustrates a cone shaped fastener provided with an expansionmember that may be provided in an attached form;

FIG. 55 illustrates a cross section through a vertebra and fixationdevice in accordance with the invention, illustrating spinal fixationthrough embedding into bondable material, and additionally illustratespositioning of a sack containing therapeutic material in conjunctionwith the device of the invention;

FIG. 56 illustrates a partial cross section through a series ofvertebrae, illustrating the embedded fastener of FIG. 55, and furtherillustrating a strap stabilizing successive vertebrae, fastened inaccordance with the invention;

FIG. 57 illustrates a cross section through a vertebra stabilized withbondable material, the material having a fastener in accordance with theinvention embedded therein, to stabilize a fracture, and furtherillustrating a strap secured to fasteners in accordance with theinvention;

FIG. 58 illustrates vibratory mixing in accordance with the invention,and further illustrates coating an implant using vibratory energy;

FIG. 58A illustrates the use of vibratory energy in accordance with theinvention, in association with an injection molding apparatus;

FIG. 59 illustrates vibratory energy in accordance with the inventionused to distribute bondable material for bonding an implant within thebody;

FIG. 60 illustrates a hand held device which controls production ofvibratory energy based upon pressure applied to the handle of the handheld device;

FIG. 61 illustrates a vibratory horn optimized to distribute vibratoryenergy throughout an area bonded by bondable material;

FIG. 62 illustrates a circuit operative to produce a signal suitable forgenerating vibratory energy, based upon a DC source provided by one ormore batteries;

FIG. 63 illustrates a generator system in accordance with the invention,including human interface elements, and control logic;

FIG. 64 is a perspective view of internal elements of a handpiece inaccordance with the invention which includes an element for generatingtherapeutic vibratory energy, and an array of vibratory elements fordiagnostic use;

FIG. 65 is a side view of the handpiece of FIG. 64;

FIG. 66 is an end view of the handpiece of FIG. 64;

FIG. 67 is a graph illustrating a phase shift between voltage andcurrent, generated during a bonding process in accordance with theinvention;

FIG. 68 illustrates a substantial change in phase shift that occurswithin a particular frequency range during a bonding process inaccordance with the invention;

FIG. 69 illustrates end effector displacement as a function of stackdrive signal, modifiable through the use of a booster or attenuator;

FIG. 70 is a graph illustrating sampling at node points, or datacollection points useful for calculating phase shift;

FIG. 71 is a graph illustrating a substantial change in impedance, whichmay be associated with an error in the bonding process;

FIG. 72 illustrates an example of a sequence of steps indicated by anoutput screen associated with a vibratory generator in accordance withthe invention;

FIG. 73 illustrates a spinal cage of the invention, inserted betweenvertebrae, and fastened in accordance with the invention;

FIG. 74 illustrates a stabilizing strap fastened to vertebrae withfasteners of the invention;

FIG. 74B illustrates a vertebral stabilizing plate having an elongatedslot engagable by a fastener of the invention;

FIG. 75 illustrates a stranded suture bound within an anchor usingvibratory energy in accordance with the invention;

FIG. 76 illustrates a device and method in accordance with the inventionfor securing one or more suture strands within an anchor which binds thestrands upon the application of vibratory energy and or compression;

FIG. 77 illustrates an anchor in accordance with the invention, operableto secure one or more suture strands through the use of vibratory energyapplied by a horn within an interior space of the anchor;

FIG. 78 illustrates a shaped end effector applying vibratory energy to atherapeutic component, with the introduction of bondable material;

FIG. 79 illustrates the bondable material of FIG. 78 applied to theunion of two therapeutic components to secure their relative positions;

FIG. 80 illustrates two layers secured in relative apposition throughthe application of vibratory energy in accordance with the invention;

FIG. 81 illustrates an end effector and one or more tubes in accordancewith the invention, the tubes operative to introduce or remove materialproximate a bonding site;

FIG. 82 illustrates an alternative to the device of FIG. 81, wherein thetubes are located within the end effector;

FIG. 83 illustrates an alternative to the device of FIG. 82, wherein twotubes are internally located;

FIG. 84 illustrates an end effector in accordance with the invention,provided with a radio frequency transmitter at an end proximate abonding site;

FIG. 85 illustrates, in accordance with the invention, an end effectorof the invention within a cannula, operative to provide a working space,and to introduce and remove materials proximate a bonding site,including tissue to be removed;

FIG. 86 illustrates a vibratory energy generating handpiece inaccordance with the invention, incorporating power circuitry, logiccircuitry, a piezo stack or other source of vibratory motion, avibratory energy booster, an end effector, and a horn;

FIG. 87 illustrates the handpiece of FIG. 86, modified to incorporate abattery and signal generating circuit for converting battery power, andfurther illustrating a housing additionally incorporating the booster;

FIG. 88 illustrates a cross section through the center of a longitudinalaxis of an expanding anchor in accordance with the invention;

FIG. 89 illustrates the anchor of FIG. 88 expanded;

FIG. 90 illustrates the anchor of FIG. 89, fastened in an expandedstate;

FIG. 91 illustrates a mesh in accordance with the invention, fastenedwithin the body using fasteners of the invention, the mesh operative,for example, to promote tissue ingrowth;

FIG. 92 illustrates vibratory fastening within a tubular structurewithin the body, vibratory fastening of at least one stent, and furtherillustrating an end effector disposed upon the end of a catheter orlaparoscopic instrument;

FIG. 93 illustrates various methods of the invention for fasteningstents or implants together within the body;

FIG. 93A illustrates an alternative method of the invention forfastening stents or implants together within the body;

FIG. 94 illustrates a method of the invention for fastening two tubularbody structures together;

FIG. 95 illustrates an alternative method of the invention for fasteningtubular body structures together;

FIG. 96 illustrates fasteners of the invention fastening into an anchorof bondable material disposed within a space within the body, andfurther illustrates a focal defect repaired in accordance with theinvention by an implant fastened with bondable material softened ormelted by vibratory energy; and

FIG. 96B illustrates a focal defect repaired in accordance with theinvention using bondable material melted or softened by vibratory energyprovided by a conforming horn in accordance with the invention.

SUMMARY

For the convenience of the reader, text is organized generally into thefollowing headings and order, although it should be understood thatcontent within a heading does not necessarily stand on its own, and allof the content is intended to be understood and interpreted as a whole.Thus, headings or captions are not intended, and should not beconstrued, to limit or modify the scope of the accompanying text.

Fastening Materials

-   -   Sulfonation    -   Metals    -   Therapeutic Substances    -   Naturally Occurring Materials    -   Polymethylmethacrylate

Vibratory Mixing

-   -   Manufacturing with Vibratory Energy    -   Bonding Parts    -   Tissue Harvesting

Fasteners

-   -   Staking Fasteners    -   Embedded Bone Cement Fastener    -   Ported Embedded Fastener    -   Offset Shaft Collar    -   Knotless Suture Fastening    -   Bonded Flange Fastener    -   Headless Fastener    -   Spacer    -   End Effector with Cartridge Heater    -   Configurable End Effector Face    -   Coated Fastening Base    -   Expanding Fastener

Parameters and Additives

-   -   Additives    -   Energy Type    -   Pressure    -   Collapse

Instrumentation and Controls

-   -   Microprocessor Control    -   User Interface    -   Frequency Sweep Tuning    -   Impedance Feedback    -   Controlled Pressure Handpiece    -   Battery Powered Vibratory Energy Generator    -   SONAR Measurement of Collapse    -   Booster/Attenuator    -   Thermal Staking    -   Color Change    -   Combined Therapeutic/Diagnostic Vibratory Generator    -   Irrigation/Suction End Effector    -   Radio Frequency End Effector

Testing

Fastening Procedures

-   -   Staking    -   Fastening into Existing Cement/Adhesives    -   End Effector for Fastening into Adhesives    -   Fastening into Implanted Device    -   Distal Fastening/Retrograde Approach    -   Spinal Fixation    -   Locking Screw Fastening    -   Resecuring or Removing an Implant    -   Fastening Dissimilar Materials    -   Fastening Combinations and Applications    -   Focal Defect Correction    -   Chain of Fastening

As indicated above, the invention relates to devices and methods thathelp stabilize tissue or implanted materials in a patient's body,including the fastening of two different tissue types, the fastening ofan implant to tissue, or the fastening of an implant to another implant.The invention additionally relates to removing and anchoring implantsinto bone cement, anchoring implants using previously implanted andhardened bone cement and adhesives, locking implants to body tissue, forexample cartilage grafts, or other implants using vibratory energy,connecting implants to porous surfaces using vibratory energy, devicesfor generating and controlling delivery of vibratory energy, and mixingmaterials using vibratory energy.

The methods and devices disclosed herein may be used in conjunction withany surgical procedure of the body. In this specification, bonding orwelding refers to the joining of parts wherein at least one partincludes a bondable material, as defined herein. Welding hereingenerally indicates joining two similar materials, whereas bondingherein generally indicates they may or may not be the same material.Thus, the invention may be utilized as a trauma bonding system for thestabilization of damaged tissue, such as fractured bones. In thisapplication, the system may include devices and methods forintracorporeal thermal bonding or mechanically interlocking ofthermoplastic material. An energy source can be used to bond or lock thematerial in place. The energy source may be resistive heating,radiofrequency, ultrasound (vibratory), microwave, laser,electromagnetic, electro shockwave therapy, plasma energy (hot or cold),and other suitable sources. Likewise, the energy source may enable aportion of material to be foamed or expanded such that two components ofthe system are secured together. Other energy sources, surgicalprocedures, and medical instruments which may be used with the presentinvention are disclosed in U.S. Provisional Patent Application No.60/968,969, filed Aug. 30, 2007, U.S. patent application Ser. No.11/689,670, filed Mar. 22, 2007, U.S. patent application Ser. No.11/671,556, filed Feb. 6, 2007, U.S. Provisional Patent ApplicationsNos. 60/765,857 filed Feb. 7, 2006; 60/784,186 filed Mar. 21, 2006; and60/810,080 filed Jun. 1, 2006, as well as U.S. patent application Ser.No. 11/416,618 filed May 3, 2006; Ser. No. 11/689,670, filed Mar. 22,2007; and Ser. No. 11/671,556, filed Feb. 6, 2007. The contents of thesedocuments are incorporated by reference herein in their entirety.

Fastening Materials

The trauma bonding and staking system and other embodiments of thepresent invention contemplates the use of any biocompatible materialbondable and/or stakable within the human body. Preferably, thismaterial can melt with the application of energy, becoming gel-like,tacky, or soft. The energy source and the technique used to bond and/orstake the material within the body can be selected to minimize or avoiddamage to surrounding body tissue. Exemplary materials that may be usedmay include polymers, ceramics, composites, and metals, although othermaterials may also be suitable for use with the invention. Generally,there are two types of polymers: thermoset and thermoplastic.Thermoplastics may be used with the present invention because they canbe softened, reheated, molded and remolded.

Some semi crystalline materials have an amorphous structure or anamorphous region within them. These materials are particularly suitablefor surgical bonding and/or staking, especially vibratory bonding andstaking. Examples of such materials include PAEK (polyaryletherketone),including PEEK (polyetheretherketone) and PEKK (polyetherketoneketone).With these special semi crystalline materials, the amorphous content ofthe polymer makes the material more conducive to vibratory energy, andtherefore a better bond or mechanical interlock is achieved. Also, alower amount of energy is needed for these materials.

The semi crystalline materials without an amorphous structure or regionhave a rigid or fixed melting point. A high level of energy is requiredto breakdown the crystalline structure before the melting occurs. Oncethe melting starts, the material very rapidly moves through thetransition area from a solid to a flowable substance, i.e. a liquid.Also, the molecular structure of semi crystalline materials absorbsvibrational energy making it more difficult to transmit the vibrationalenergy from an energy-producing instrument to the interface of the partsbeing joined. When this material is used in surgical screws, plates,rods, etc., care must be taken to avoid over melting and weakening ofthe implant. The temperature, time, and pressure must be closelymonitored and controlled with semi crystalline materials or the implantwill fail.

The polymers used in the present invention, such as PEEK and PLLA, haverandomly arranged molecules allowing vibrational energy to pass throughthe material with little attenuation. As such, the material requiresrelatively little vibratory energy to make the material soften andbecome tacky. This small amount of energy or heat needed to bond orstake PEEK and PLLA helps avoid or minimize the likelihood of tissuenecrosis.

Dissimilar materials can also be mechanically interlocked. Staking isdefined herein as the process of melting and reforming a piece, such asa stud, to mechanically lock a material in place. It provides analternative to bonding when two parts to be joined are made ofdissimilar materials that cannot be bonded, or when simple mechanicalretention of one part relative to another is adequate.

In this application, the term “bondable” or “bondable material” is usedto refer to the materials discussed above, as well as any material,suitable for use in in vivo applications, which can be softened and madeflowable by the application of heat (such as heat produced withvibratory energy such as ultrasonic energy), and which, when softened,may become tacky and will bond to other materials and will flow to fillavailable space. Thus, the material may be thermoplastic, but it mayalso exhibit tackiness or bonding ability when in its plastic form. Manymaterials suitable for in vivo applications are made of or incorporatesuch bondable materials. Generally speaking, the amount of heat neededto softened and make flowable should be within a temperature range thatdoes not produce substantial thermal tissue necrosis. Alternativelystated, the amount of heat required to soften the bondable materialduring vibratory bonding is substantially confinable, due to the thermalproperties of the bondable material, to an area of contact between twoobjects which are being bonded, thereby protecting living body tissuenear the contact between the two objects from substantial thermal tissuenecrosis. Selection of such material is within the ordinary skill of theart.

Sulfonation

Polymers used in methods and devices of the invention may be sulfonatedto be wettable, or hydrophilic, using any of a variety of known methods,including a method of exposure to sulfur dioxide, an oxygen donatinggas, and a free radical producing energy, as described in U.S. Pat. No.6,066,286, the contents of which are hereby incorporated by reference. Ahydrophilic surface presents the opportunity for improvedbio-integration of implanted devices, including an enhanced surfacestructure for tissue ingrowth, should that be an objective. Moreover,therapeutic substances may be readily incorporated into the sulfonatedsurface layer, and may more readily transfer a target therapeutic doseinto the body. Through sulfonation of bioabsorbable polymers, fastenersmay be formed to elute therapeutic substances, with the aforementioneddesirable benefits.

Further, a wettable surface may be used to reduce friction on one ormore bearing surfaces, such as articulating bearing surfaces in joints,creating a more optimal and longer lasting replacement or repair. Thewettable surface can be inlaid into the bone surface, including aninlaid articular surface. One mechanism of operation for the implantcontaining hydrophilic materials is the formation of a molecular linkagewith body fluid, thereby promoting lubrication, tissue ingrowth, andbiocompatibility.

Metals

In accordance with the invention, metals are advantageously connectedwith fasteners incorporating polymeric materials. Any of a variety ofmetals may be used, either smooth or formed with at least portions offoam metal, or a roughened or porous surface, or formed with cavities orother shapes upon which polymeric material may mold, enter, adhere, orotherwise affix. The polymer is softened in accordance with theinvention through the application of heat, including heat created usingvibratory energy, to become tacky, or sufficiently softened in order tobond on a microscopic level, or a macroscopic level through adaptationto the surface structure of the metal. For use in vivo, biocompatiblemetals are used, including stainless steel, nitinol or other SMA (shapemetal alloy), tantalum, porous tantalum, titanium, cobalt-chrome alloys,and other metals such as are known to those skilled in the art.Additional related information, including bonding polymers and metals,and polymer to polymer bonding of implant materials, may be found inU.S. Pat. No. 5,163,960 entitled “Surgical devices assembled usingbondable materials”, and U.S. Pat. No. 7,104,996 entitled “Method ofperforming surgery”, the contents of each of which being incorporatedherein by reference.

Therapeutic Substances

The fastening device of the present invention may include therapeuticsubstances to promote healing. These therapeutic substances may becombined with the materials used to make the device. Alternatively, thetherapeutic substances may be impregnated or coated on the device.Time-released therapeutic substances and drugs may also be incorporatedinto or coated on the surface of the device. The therapeutic substancesmay also be placed in a bioabsorbable, degradable, or biodegradablepolymer layer or layers, or in cavities disposed in a fastening deviceof the present invention.

Naturally Occurring Materials

In addition to PEEK and the other polymers described herein, theimplants, devices, and methods of the present invention may use keratin,a naturally occurring polymer. Keratin may be vibratory bonded or stakedto itself, to other implants, or within tissue. This may be performed inthe operating room or intracorporeally. Keratin may be bonded tocollagen or to other known polymers.

Another polymer that can be used with the present invention is a classof natural materials, called polyhydroxyalkanoates- or PHA polymers.

Polymethylmethacrylate

Fasteners of the invention may be coated with polymethylmethacrylate(PMMA), in order to promote bonding with PMMA used in the body, or PMMAcould be incorporated into polymer of the fastener, or deposited withincavities or shapes formed in the fastener surface, including threaded,roughened, porous, or nano textures. A fastener may be thus coated withPMMA, or formed entirely of PMMA, and may be heat bonded, advantageouslyusing ultrasound, to another PMMA surface or an adhesive surface,otherwise as described herein with respect to bone cement.

Vibratory Mixing

In accordance with the invention, vibratory energy, for exampleultrasound, is used to mix materials to be used in formulating implantsof the invention, for mixing adhesives and cements, and for admixingtherapeutic substances into implants and substances. Materials may bemixed in a production or laboratory setting, or in the operating roomimmediately before implantation. Vibratory energy is applied to themixing bowl or chamber, to promote even distribution of materials, andthe release of gases, gaps and voids, resulting in a denser, more evenmixture. In addition, the temperature or pressure, as well as otherparameters, may be applied along with vibratory energy, to produce anoptimal result for the mixture.

To improve mixing, the energy level and frequency may be tailored to theparticular mix constituents. For example, low energy or longerwavelengths may be used for polymeric materials mixing, particularlyamorphous polymers, and shorter wavelengths may be advantageously usedfor metallic materials and denser polymers, and PMMA. Other frequenciesmay be used, both lower and higher than the frequencies commonly used inultrasonics, for example within the audible range, or in the megahertzrange.

Polymer, adhesive, binding material or grouting agents, including bonecement, may be maintained or converted to a liquid or viscous formwithin the mixer, therapeutic substances, including pharmaceuticals, mayoptionally be admixed, and an implant may be dipped into the mixture forcoating. The dipped implant can include any material to be implanted,including metals and polymers. It is advantageous for the dipped implantto maintain its shape until the coated polymer cools and hardens. Inthis manner, an implant such as a stent or arthroplasty component may becoated to elute a therapeutic substance, while maintaining appropriatephysical dimensions and properties. Further, the coated implant may thenbe fastened within the body using the methods and devices described inthis specification, the coating forming a substrate for proximal and ordistal heat fastening, including ultrasonic fastening. Vibratory energyimparted to the mixing chamber during coating further serves to improveinterdigitation and a close, conforming coating of the implant.

Vibratory mixing as described, advantageously combined with changes inmixing parameters, such as temperature and pressure, may be used toalter the polymerization characteristics of polymers within the mixingchamber. Accordingly, the resultant polymer may have properties bestsuited to the procedure contemplated. Properties affected may vary, butmay include changes in density, porosity, flexibility, hardness, color,and smoothness.

Manufacturing with Vibratory Energy

In addition to mixing, as described herein, vibratory energy may beadvantageously employed in manufacturing requiring a mixing step.Operating parameters such as temperature and pressure may be varied, incombination with the application of vibratory energy to mixing orstaging apparatus. With respect to injection molding, in particular,vibratory energy is applied to the injection molding equipment, toimprove performance of the injection molding process, as well as topotentially improving the resulting injection molded parts.

Vibratory mixing and packing of the invention is particularly useful inmold filling and fabrication of precision parts requiring a tortuousfill path, having delicate structures, or having features on thenanometer scale.

A biologic matrix including fibers, such as collagen fibers, can be moreuniformly mixed and formed into a polymer or biologic collagen scaffoldin combination with vibratory energy as described. The matrix mayinclude cells or pharmaceutical agents, including chemotherapeuticagents, antibiotics, cell growth agents, growth inducing factors, andproteins. Moreover, manufactured or harvesting tissue, cells, or cellproducts may be integrated into a mixture that is molded to conform to abody surface or cavity, including epithelial surfaces, or to an implant.

Bonding Parts

When bonding parts with adhesive, it can be a challenge to evenlydistribute adhesive between the parts to be fastened. In accordance withthe invention, vibratory energy, for example ultrasonic energy, isapplied to either or both parts, and or the adhesive or grouting layer,to promote movement of the adhesive throughout the interstitial spacebetween the parts, whereby a more uniform, reliable and predictable bondis formed.

In a medical context, it is often necessary to use an adhesive, bindingmaterial or grouting agent, for example PMMA or bone cement, to securean implant, particularly an arthroplasty component, within the body. Theimplant may have a projection which enters a space within the body, forexample the medullary canal of a bone, or may lie upon the surface ofbody tissue. In either application, it is advantageous to create uniformcontact between the implant, adhesive, and body tissue, in order toavoid the formation of gaps or voids, appearing as lucencies inradiography.

In accordance with the invention, vibratory energy, advantageouslyultrasonic energy, is applied to the implant, body tissue, adhesivelayer, or a combination of same, to improve movement of the adhesivethroughout the interface between the implant and the body tissue to beadhered. This is particularly effective when combined with pressure,applied to the interface, as by applying pressure to push the implantagainst a bone surface. An example includes the implantation of a tibialinsert, including insertion of an implant stem into the tibial medullarycanal. Vibratory energy is applied to the upper portion of the tibialimplant, near or on the bearing surface, or along the sides of theimplant, as the stem is inserted into the canal. Vibratory energy may becontinued for a period of time thereafter, until an even distribution ofadhesive is achieved. In this example, adhesive enters the smallcancellous bone interstices, as well as surface formations of theimplant, to improve the bond between the implant and the body.

Tissue Harvesting

In accordance with the invention, tissue is harvested by placing aharvesting tool with a holding area or chamber, such as a hollow coringdrill, upon or within body tissue and applying vibratory energy to theharvesting tool, tissue, or both. Vibration, such as ultrasonicvibration, is applied to cause cells to become dislodged, freely mobile,or movable, whereupon they may be collected in the holding area. Cellsmay be further removed by applying lavage, pressure, suction, orabrasion. In a reverse process, vibratory energy aids in theimplantation of cells, through modification of the body tissue surface,rendering the surface more conducive to implantation, and improvestransfer of cells from the holding area to the implantation site. Theuse of vibratory energy is advantageously applied in the harvesting orimplantation of fetal cells, for example.

The application of heat or other environmental change, or the additionof therapeutic elements, may be used to improve performance ofharvesting or implantation. For example, including injectible polymersmay improve bonding, the addition of nutrients may improve cellviability, or the addition of pharmaceutical agents may improvecompatibility.

Fasteners

Fasteners of the invention may be configured to matingly engage otherimplants, being urged or locked into an advantageous orientation througha molded or otherwise formed three dimensional configuration.Alternatively, fasteners of the invention may be formed to maximizebonding surface, or to modify strength in designated locations.

Staking Fasteners

In another embodiment of the invention, a tackable fastener is sized tobe insertable through a stab wound, drilled portal, or other focusedaperture. The body of the fastener may be provided with an aperture orpassageway through which another fastener may pass, for example asuture, cable, or another similar fastener. The fastener may further beprovided with a ramped or angled face which advantageously is providedwith a pointed or constricted end, operative to pierce material to beheld thereon. The distal, or non-pointed end of the fastener may besecure using the distal fastening method described in thisspecification, or alternatively by any known means, including a pressfit into a bore, or attachment using the aperture described above. Ifmaterials are to be held on the fastener, they are passed over thepointed end of the fastener, pierced by the fastener if needed, and areoptionally followed by a load spreading device, such as a washer. Whenall materials have are held, a cap is placed upon or formed on thepointed end of the fastener. In one embodiment, and end effector isplaced upon the pointed end, the pointed end advantageously formed withan alignment bore or other surface which mates and aligns with the endeffector. Vibratory energy, such as ultrasonic energy, is then used tomelt the tip and form the melted material into a cap which retains andthus stake the held materials.

Embedded Bone Cement Fastener

As is described in further detail, below, fasteners may be embeddedwithin previously solidified bone cement, for example PMMA or otheracrylic based material. In an embodiment in accordance with theinvention, an anchor is connected to an end effector of a vibratoryenergy generator. The anchor is adapted to enter and engage cement oradhesive that has been locally melted by vibratory energy, and to besecurely retained therein once the cement has cooled and hardened.

The end effector may be provided in any of a variety of shapes, oneexample being an elongated rod or shaft, connectable to a hand piece ata proximal end, and operative to transmit vibratory energy at a distalend. The fastener is adapted to connect to the distal end of the endeffector by mechanical interlocking, as by a bore on either device sizedto receive a post on the other, optionally with threading. Othermechanical connections are contemplated, including twist lockconfigurations, friction fitting, or adhesive attachment. The mechanicalconnection must be operative, however, to communicate the vibratoryenergy from the end effector to the fastener.

The fastener is adapted to be securely retained within the groutingagent or adhesive, in one embodiment, by being provided with a shaped orcontoured surface upon which the adhesive may grip once hardened. Aroughened or porous surface may be provided alone or in combination witha shaped surface, the adhesive obtaining purchase thereupon.

The fastener may further be provided with a taper at a leading end whichfirst enters the adhesive. The taper improves performance, at least, bypromoting accurate tracking and movement of the fastener into theadhesive, piercing tissue, and facilitating initial melting byconcentrating vibratory energy over a smaller surface region.

Once anchored, the end effector and embedded fastener may remainconnected, or the end effector may be removed and another fastener maybe connected to the embedded fastener, connecting by mechanical means asdescribed, including threading. In a further embodiment, a fastener suchas described in the related references cited and incorporated byreference herein may be fastened to the embedded fastener of the instantinvention, then secured in its respective manner. For example, a pointedpolymeric fastener may pierce tissue and enter the embedded fastener,then connecting by, for example, press fitting or threading into a borewithin the embedded fastener. The fastener may be distally fastened intothe bore using vibratory energy as detailed in this specification. Oncesecured within the embedded fastener, a head portion of the polymericfastener may then be formed to cap and secure the tissue, using avibratory end effector, including an ultrasonic end effector.

Ported Embedded Fastener

In a further embodiment of the invention, the embedded bone cementfastener described above is provided with one or more radial gaps,chambers, or ports, extending from a central bore. A polymeric fasteneris inserted within the central bore, and vibratory energy is applied tothe polymeric fastener, whereby polymer at the interface between theembedded fastener and the polymeric fastener melts. When the polymermelts, and particularly as pressure is applied to the polymeric fastenerin the direction of insertion, polymer enters the ports, flowing in adirection away from the central bore. When vibratory energy isdiscontinued, the polymer solidifies, and the polymer faster isthereafter secured within the embedded fastener.

Offset Shaft Collar

In one embodiment, a fastener has a shaft, which may or may not bethreaded, which terminates in a tip, and a head that is provided with arecess into which a pin of an end effector may be matingly engaged. Thehead and or shaft has a lip or flange or collar extending partiallyaround the circumference of shaft. This flange corresponds with achannel formed in a typical spinal implant. In this manner, fasteners ofthe present invention may be adapted to be used in applications wheretraditional bone screws are used.

Knotless Suture Fastening

Although the present invention includes fastener concepts that eliminatethe need for sutures (so-called “sutureless fastening”). The presentinvention also includes fastener concepts that use suture, but withoutthe need for knots (so-called “knotless fastening”). In one embodiment,a system includes an anchor, having a bore configured and dimensioned toreceive a shaft of the tack. A channel created by the forked end of theshaft extends through the tack such that one or more sutures can extendthrough both the anchor and tack. When the tack is partially inserted inthe anchor, the suture can freely move; however, as the tack is furtherinserted in the anchor, channels misalign and trap the suture. Whenbonding of the anchor and tack occur, knotless fastening of the sutureis achieved.

In a further embodiment, a suture is passed through body tissue, and oneor more strands pass through a gap or aperture in an anchor comprisingbondable material. An end effector of the invention is applied to theanchor to cause melting of the bondable material, trapping the suturestrands therein. If the anchor and sutures are of the same material, theanchor and sutures may become welded. Alternatively, the anchor may beprovided with a tortuous pathway for the strands, such that as vibratoryenergy is applied to the anchor, the anchor is deformed and the suturestrands are mechanically locked within the anchor.

Further, the end effector may be driven into the anchor with vibratoryenergy, thus displacing material of the anchor to cause compression ofthe suture strands, binding the suture strands within the anchor. Theend effector is thus advantageously shaped to penetrate and displacematerial along a predetermined path and direction. For example, fastener826 of FIG. 30 is well adapted to penetrate a monolithic anchor,particularly where there is no established entry portal.

In an additional embodiment, more than one end effector may be appliedto an anchor from opposing sides, whereupon vibratory energy andpressure caused by pinching of the anchor between the end effectorsoperates to compress the anchor and thereby bind one or more suturestrands within the anchor. The end effectors may further be shaped tohave contact the anchor along an increased surface area, improving thetransmission of vibratory energy in the anchor.

Bonded Flange Fastener

In a further embodiment of the invention, a fastener is provided adaptedto bond an implant to body tissue, the fastener having the form of oneor more flanges or tabs projecting from the implant, and being formed ofa heat softenable and bondable material. This fastener is advantageouslyused where the implant has the form of a liner, surface layer, or shell,and thus is advantageously formed without projecting mounting posts, orholes through which a fastener may pass. Examples include replacementsfor articulating surfaces of a joint, including the acetabular andcondylar surfaces.

In one embodiment, a first implant component is fastened to body tissueat a location beneath or adjacent to the intended implantation site forthe liner implant. The first implant may be attached to body tissue inaccordance with any known manner, or in a manner disclosed herein. Thefirst implant has mounting projections positioned to cooperate with theflanges of the liner. After the first implant is secured, the liner ispositioned in the body, and the flanges are attached to the mountingprojections using vibratory energy. The flanges and mounting projectionsmay be provided in the form of mating flanges, flange and posts, matingposts, or any other cooperating projections which may be heat bondedtogether upon the application of vibratory energy. When heated thecooperating flanges and projections soften and bond together, and arefurther driven before hardening to lie in a position which will notinterfere with proper functioning of the body.

In another embodiment, the flange is fastened directly to bone or bodytissue adjacent to the site of implantation.

To further secure the liner, adhesive may be applied to an inner surfaceof the liner before mounting and attachment.

Headless Fastener

In another embodiment of the invention, a fastener is fastened in amanner described herein, the fastener passing, for example, through anaperture or bore; however, the fastener is not provided with a head orwidened portion operative to prevent the fastener from passingcompletely through the aperture. For distally secured fasteners,described herein, there is a reduced possibility for the fastener topass completely through the aperture, as the distal end of the fasteneris securely fixed. Where the point of fastening is fixed relative to thelocation of the entry of the bore, a fastener head can be avoided. Inthis manner, the fastener may have an excess length, and be trimmedflush after being secured. Alternatively, the fastener may be providedwith a length predetermined to lie flush with a surface through whichthe fastener is passed.

In a further alternative, a head portion may be bonded using vibratoryenergy, as described herein, after the fastener has been distallysecured and trimmed.

Spacer

Implants may be positioned and secured in a precise location, inaccordance with the invention, through the use of a progressivelywidening spacer, such as a spacer having a conical, ramp or wedge shape,affixed in a predetermined location, through the use of vibratoryenergy, for example ultrasonic energy. The implants include a bondablematerial as described herein, or alternatively, fasten to a surfaceincluding bondable material. One or both of the surfaces may be providedwith a roughened, porous, or shaped surface, to which melted materialmay enter or surround, thereby becoming affixed after cooling.

Due to the ramped shape of the implant, a progressive insertion of thedevice produces a concomitant displacement of the implant to be affixed,relative to the body tissue proximate the implantation site. Spacers maybe placed at different locations, so that they may cooperativelydisplace the implant, and offer greater strength when affixed.

End Effector with Cartridge Heater

A small cartridge heater may be used to deliver thermal energy, disposedwithin the end effector. To prevent heat build up on the outside shaft,an insulating region may be formed between the heater and the shaft.

Configurable End Effector Face

Further in accordance with the invention, an instrument may includedifferent horn or end effector configurations within one design,retractable to alter the surface configuration of the tool. Theinstrument can be configured to have a bonding-surface face, a bondingface, and a contouring face.

Coated Fastening Base

In accordance with the invention, an implant is coated with a bondablematerial, and placed in the body as a point of attachment for otherimplants. The coated implant is advantageously shaped to provide asurface for attachment of numerous fasteners, or one or more fastenersat a variety of possible locations. Fasteners may be bonded to thecoated implant using proximal or distal vibratory fastening, asdescribed herein, or a combination of vibratory and mechanicalfastening.

Expanding Fastener

In accordance with a further embodiment of the invention, an expandinganchor is provided, adapted to pass through an opening into a hollowspace, and expand within the hollow space thereby resisting withdrawalthrough the opening. The anchor is fastened using vibratory fastening inaccordance with the invention.

Parameters and Additives

Monitoring and controlling bonding parameters ensures proper bonding ofthermoplastics. Parameters include, but are not limited to, the type ofenergy to emit, type of thermoplastic material, the size andconfiguration of the implant, the thickness of the implant, implantsurface geometry, the aqueous environment, energy time, energy power,and frequency of the energy, amount of pressure applied to the implantduring and after application of the energy, the geometry of the horn,the boost or attenuation of the end effector, the density of theimplant, the amount of collapse of the thermoplastic material, the depthinto tissue the implant is to be inserted, and the type and amount ofany therapeutic agent that may be delivered.

There are several factors commonly encountered in vivo that effectbonding or staking of thermoplastic materials. One is how hydrophilic amaterial is, or the tendency of a material to absorb moisture. If toomuch fluid gets between the parts it can decrease the bond or createfoam which prevents proper bonding of the materials. Therefore, thebonding of thermoplastics may be performed under vacuum/suction, or ahermetic seal may be placed around the thermoplastic during the bondingprocess.

Additives

In addition to or in place of reducing moisture from the bonding area,certain agents can be used to aid in the bonding process. Such agentsmay include filler material, glass filler, glass fiber, talc, andcarbon. The agents may be placed at the bond site as a temporary bondingenhancement means or may be a permanent agent to enhance the bonding.

In addition to avoiding release agents, pigments, and moisture, thestaking and/or bonding of thermoplastic materials may be furtherenhanced by adding minute metallic material to the polymer. The metallicmaterial may be metal flakes or metal dust. Examples of such metalinclude iron particles, chromium, cobalt, or other suitable metals. Themetal may be embedded within the polymeric material to enhance thethermal properties. Alternatively, or in addition, the metal may beapplied to the surfaces of the polymeric material. Energy applied to thepolymer would heat both the polymeric and metallic material providing afaster and more uniform thermal profile. It is contemplated that glassfillers, carbon fillers, talc, or combination thereof may also be usedin addition to or in lieu of the metallic material.

Energy Type

Other factors affecting the thermal characteristics of thermoplasticsinclude size, thickness, surface geometry, material properties of thethermoplastic, and the type of host tissue involved in the bond orstaking, i.e. soft, hard, dry, wet, or moist tissue.

Furthermore, how the thermoplastic is staked, welded or bonded is animportant characteristic of obtaining a robust mechanical interlock orthermal bond. The type of energy used is one way to control the process.As previously mentioned, various energy sources may be used to bondand/or stake polymers. In an exemplary embodiment, two or more differenttypes of energy may also be used. For example, vibratory energy may beused to bond a polymeric component to another component, while resistiveheating may be used to contour the surface or change the geometry of thematerials. The surface of the component may be smoothed out or sculptedusing resistive heating.

The intensity and duration of the energy source impacts the quality ofthe bond or mechanical interlock. For instance, the amount of energyused affects the thermal properties. Therefore, the energy may becontrolled by the operator depending on the component to be bonded orstaked. A switch, dial, or other control may be placed in connectionwith the energy source to vary the intensity of the energy applied. Forexample, the amount of current supplied to the instrument may be variedor controlled. It is also contemplated that the amount of time thatenergy is applied may be controlled not only by the operator but alsovia radiofrequency, optical, radiowave, etc. A computer or othermicroprocessor may send signals to the energy emitter to turn the energyon and off.

Pressure

Controlling the pressure applied to the thermoplastic material also maybe used to affect the process. During bonding or staking, a handpiece,an anvil, a horn, end effector, or combinations thereof may be used toapply controlled force against the component. After completion, whilethe material is cooling, the force may continue to be applied to ensureproper bonding and/or mechanical interlock of the materials.

Collapse

Controlling collapse is another factor in achieving an effectivethermoplastic bond or staking. For instance, the time and materialcollapse may be monitored to ensure a proper effect. A measurement ofthe change of the material being bonded or staked may be made todetermine when complete. This may be accomplished by usingmicro-switches to provide precise, binary control of the mold. Also, byusing a linear variable displacement transducer (LVDT), the controlsystem can monitor the bond more precisely.

Furthermore, collapse may be controlled or monitored through the use ofa mechanical stop on the fastening device itself or on theinstrumentation. The mechanical stop would prevent collapse after apredetermined point. It is also contemplated that the collapse could bemonitored by other methods such as optics, laser, or even a hall-effectsensor. All of the above-mentioned parameters may be monitored andcontrolled by a computer.

Instrumentation and Controls

Any known energy emitting instrument may be used with the surgicalsystem of the present invention. The instrument may produce energy suchas resistive heating, radiofrequency, ultrasound, microwave, laser,electromagnetic, electro shockwave therapy, plasma energy (hot or cold),and other suitable energy. The instrument may be a vibratory energyhandpiece with a sheath to cover and protect an end effector and hold afastener. The sheath may have a small counter bore at its tip to cover aportion of the cap. The tip of the end effector may have a small postprotruding from the bonding face, operative to press into a bore in thecap of the fastener, to align the fastener post into the anchor bore andkeep the cap tight against the end effector face.

Microprocessor Control

In accordance with the invention, a digital signal processor (DSP)simplifies additional modes for fastening control. Whether or notanalysis is performed by a DSP, other processor type, mechanical means,or by the practitioner, modes may include any or all of the following:

monitoring the phase angle differential between voltage and currentduring use, and making changes to the signal, including the frequency,to maintain a resonant frequency;

varying the output voltage while monitoring the bond power;

monitoring the stroke using a sensor in the handpiece or end effector;

varying the drive voltage while monitoring the current and voltage, inorder to calculate the minimum impedance;

calculating the total power/energy applied to the bond; and

monitoring the Eddy or Foucault currents created by movement of the endeffector, wherein as the end effector vibrates, a magnetic field ischanged, whereby the movement of the end effector can be tracked, themovement indicative of melting activity;

calculating the amount to which the fastener has collapsed or shrunk.

The methods may be combined, and further, the total time during whichvibratory energy has been applied may be monitored, with a set minimumor maximum time being applied. The methods enable adjustment of thesignal for variations in the environment and loading during a surgicalprocedure.

The control modes described above may be combined with input or measuredparameters automatically by processor control, or at the election of thesurgical practitioner. In this manner a matrix for overall control iscreated by the selected parameters, and selected control modality.

User Interface

The surgeon may manually control the parameters, or the parameters maybe controlled using automation, including using a microprocessor orcomputer. In accordance with the invention, a generator control unit isprovided having connections for grounding and a signal. The generatoradvantageously includes a user interface comprising gauges orindicators, and in one embodiment an LCD or similar output screen. Auser keypad is provided to move a cursor or indicator on the outputscreen, whereby parameters can be selected and entered. A footswitch maybe provided to enable the surgical practitioner to more easily activatethe generator.

A staking or fastening process of the invention begins by either pushingthe generator footswitch or by using a control on the hand piece, or byoperating two or more controls together, if it is desired to renderinadvertent activation less likely. Upon starting, the generator mayfirst perform a system check. The software may also check for propergrounding, ground offset issues, as well as other vital circuits. Ifthere are errors with the system or the grounding, the generator cangive a visual or audible indication that an error has occurred, and thevibratory signal generator may be disabled to prevent inadvertent use.

In accordance with a further embodiment of the invention, the surgicalpractitioner enters information pertaining to the surgical procedurethrough interaction with the user interface, which includes a cursorkeypad and output screen on the generator. It should be understood thatan alternative and potentially more sophisticated and complete interfacemay be obtained by connecting a computer (not shown) to the generator,via a known method including USB, Bluetooth or network connection.Moreover, the generator interface may be programmed for the varioustypes of surgeries and surgical operating parameters expected to beencountered, and the generator may thereafter be disconnected from thecomputer during the procedure.

Once programmed, the output screen contains menus offering the surgicalpractitioner options relevant to the procedure to be performed,including the type of procedure, and any or all of the parametersdescribed in this specification. In this manner, the practitioner hasthe ability to input the correct procedure and real-time parameters, inorder to enable precise control in the use of the generator. Further,the generator can perform a sophisticated analysis in order to determinethe correct operating parameters, including for example frequency,wattage, and pulsing, and the generator may further independently varyone or more parameters over time. Accordingly, the practitioner need notmake the complex calculations necessary in order to achieve a secure andreliable fastening, and thus time is saved, and the potential for erroris reduced.

Frequency Sweep Tuning

If no errors are detected, the system may then sweep a frequency range,such as from about 38.5 kHz to about 43.5 kHz, to tune the circuit.Current measurements may be used to find the resonate frequency of thesystem, which in some embodiments may be close to 41 kHz. The ultrasonicsignal is then sent to the hand piece where a resonator turns thewaveform into linear movement.

Impedance Feedback

To help ensure a properly executed bond or staking, the instrument ofthe present invention may provide a positive feedback system. One way toprovide user feedback is by measuring and controlling the impedance ofthe vibratory generator. This feedback system is based on the fact thatthe load placed on the end effector affects the impedance of the system.That is, the pressure put on the end effector by the object to be bondedor staked changes the impedance in the handpiece, and more particularly,of the piezo stack and associated electronic circuit.

By first transmitting a low power vibratory signal through the endeffector, the impedance of the handpiece can be measured with nopressure. This establishes a baseline impedance. Then, the end effectormay be subjected to known pressures, and the voltage and current may bemeasured to calculate the impedance for each pressure. Therefore, when asurgeon or other operator applies pressure from the end effector to athermoplastic implant to be bonded or staked, the actual amount ofpressure can be fed back to the operator because the pressure can becorrelated to a known impedance. The pressure and impedance of thehandpiece may be monitored throughout the thermal profile.

Alternatively, or in addition to the signal, the microprocessor can stopenergy emission until the correct pressure and impedance is achieved,then the bonding may be resumed either automatically by themicroprocessor or manually by the surgeon. If inadequate pressure isbeing exerted, the bonding instrument may operate in a pulse mode tomaintain material in a near-bond state. This may allow the bonding tomore rapidly continue when adequate pressure is once again beingapplied.

By monitoring handpiece impedance, changes to the environment, such asmoisture, ambient temperature, aqueous conditions, etc., may beautomatically compensated for by adjusting the drive waveform of thevibratory energy. As the impedance, Z, of the handpiece changes, thetotal power delivered also changes. By increasing or decreasing thedrive voltage to compensate for the change in the impedance, a constantpower can be delivered.

Controlled Pressure Handpiece

In accordance with the invention, a tool for producing vibratory energyis provided with a gauge positioned to respond to a differential betweena pressure created by applying a force to the handle, and the physicalresistance presented at the end effector. When excessive force isapplied, a response is generated, operative to warn the operator and orreduce power of the vibratory signal. When insufficient force isapplied, the operator is likewise warned, and or power is not yetapplied to produce vibration.

In one embodiment of the invention, a series of electrical contacts areinterposed between the handle grip and the end effector. Springs respondto relative movement of the handle and the end effector, to position thecontacts with respect to each other, in order to open or closeelectrical circuits. These circuits may be connected directly to a powergenerator, or may pass to mechanical or electronic circuits whichinitiate a warning or a change in power level.

Battery Powered Vibratory Energy Generator

A handheld or portable vibratory generator has a requirement for asubstantial amount of current, at high voltage. In accordance with theinvention, an inverter is provided to convert a DC battery signal into asuitable sine wave signal, and a step-up transformer is provided toincrease the voltage to an effective level. In one embodiment, multiplemosfet devices are used in parallel, advantageously provided in pairarrays, to provide for an adequate amount of current. A microprocessorcontrols power to the mosfet array pairs, alternately switching powerbetween them, in order to produce an alternating current within atransformer. Additional control circuitry modifies the signal parametersto enable precise bonding, as described herein.

SONAR Measurement of Collapse

In another exemplary method, collapse of the fastener may be monitored,such as by the use of SONAR. Collapse is the distance a thermoplasticfastener or implant shrinks in height when vibratory energy is applied.For example, some thermoplastic fasteners have been found to shrinkabout 20 percent in height and increase 30 percent in width when bonded.For fasteners having two pieces, such as a cap and an anchor, theattenuation of the reflected vibratory waves changes as the two piecefastener becomes one piece. This change in attenuation may be monitoredto alert the surgeon or operator when the bond or staking is complete.Furthermore, a vibratory transducer could be used in conjunction withthe end effector to detect the change in acoustic impedance/attenuationof the site. This signal may be monitored by a microprocessor/controlleror data signal processor (DSP) and data may be automatically interpretedto indicate whether the bond was successful.

Booster/Attenuator

In another embodiment in accordance with the invention, peak to peakmotion, or amplitude of the vibratory horn is controlled using a boosteror attenuator after the piezo stack. Control is further achieved by thegenerator through modulating the power, or amplitude, of the highfrequency signal.

Thermal Staking

Staking or fastening of fastening devices of the present invention couldalso be performed using thermal energy. The process for thermal stakingis similar to the one used for vibratory, except that it may not benecessary to tune the system. The energy signal sent to the stake can beeither AC or DC. To allow for longer heater life, a pulse widthmodulated (PWM) signal could be used. The PWM signal allows for theenergy to be rapidly switched on and off with a varying duty cycleproportional to the total system energy needed for the stakingenvironment.

Color Change

It is also contemplated that the material being bonded or staked maychange color or visible appearance as heat, vibrations, or vibratoryenergy is applied for a predetermined time and a predetermined frequencyand wattage.

Combined Therapeutic/Diagnostic Vibratory Generator

In accordance with the invention, a vibratory generator includescircuitry and is otherwise adapted to perform diagnostic as well astherapeutic tasks. Diagnostic tasks include mapping or visualization ofa target location. Information gathered during the diagnostic phase canbe used by the surgical practitioner to determine optimal settings for asubsequent therapeutic use of the device, or the information may bedirected to a microprocessor, which may include a DSP, which will thencarry out or suggest optimal settings to the practitioner.

Diagnostic information may include the size of implant needed, as wellinformation pertaining to the microclimate within the intendedtherapeutic field.

In one embodiment, diagnostic ultrasound is produced by an array of lowpower crystals, and therapeutic ultrasound is produced by a stack ofcrystals. In this manner, both structures can be packaged within asingle handheld device. Accordingly, a single microprocessor mayadvantageously be used to control both crystal configurations based onseparate algorithms for each.

Irrigation/Suction End Effector

During vibratory or ultrasonic bonding, the presence of liquid ormoisture can impact the performance and quality of the bond. Oneapproach to ensuring a consistent and reliable bond, as described inthis specification, is to adjust the bonding parameters according to theamount of observed or measured moisture within the zone or area ofbonding. Another approach in accordance with the invention is to removemoisture from the bonding area, by introducing an input stream of gas orliquid, or by applying suction/aspiration proximate the bonding site. Inone embodiment, a tube is attached to a vibratory end effector, whereinthe inlet for aspiration, or conversely the outlet for a gas or liquidstream, is positioned at a location near where bonding is to take place.

In a further embodiment, a first tube introduces an input stream of gasor liquid, and a second tube is placed proximate thereto, operative toform an output stream to collect the gas or liquid via suction, togetherwith any debris collected and carried therein.

An advantage of the aforedescribed embodiments is the removal of debrisgenerated during the bonding process, which may include flash formed atthe bonding periphery, as well as any other material or body tissue thathas vibrated loose or otherwise become loose within or near the bondingarea.

The first or second tube may be fastened to the outside of the vibratoryend effector, or may alternatively be formed as one or more channels orpathways within the end effector. In either embodiment, switches orcontrols for activating an input or output stream may be provided on thehandpiece connected to the end effector, or on a foot switch or handoperated remote, or may be activated by voice control.

Radio Frequency End Effector

In another embodiment, a radio frequency transmitter is providedproximate the end effector, operative to break down or destroycontaminants within the bonding area, including moisture orparticulates. Shielding is appropriately placed in order to safeguardany nearby body tissue or material which might be vulnerable to straytransmissions.

Testing

Once a fastener or other implant is vibratory bonded or staked, thesurgeon can apply a quick tug on the assembly to verify the bond orstaking was completed as intended. An end effector in accordance withthe invention includes a post which emits vibratory energy, and whichenters a bore or receptacle in a fastener. After bonding, the surgeonmay actuate biasing prongs which dig slightly into the material of thefastener, so that the surgeon may now pull or tug on the instrumentproximally to verify that the fastener is securely bonded or staked inplace. A strain gauge may be used to measure and display to the surgeonhow many pounds of pull strength is being put on the fastener.

In accordance with an embodiment of the invention, a frame is providedwith an aperture through which a fastener body may pass, sized toprevent passage of a fastener head. The device may thus test the holdingstrength of a distally bonded connection, as well as proximal bondincluding a head formed with vibratory energy. A strain gauge, springscale, or other suitable measuring device is connected to the frame, anda force is applied in a direction away from the fastened connection. Theresults are observed and recorded, together with the parameters underwhich the connection was formed and tested.

To aid in determining the exact conditions under which fastening wasaccomplished, an electronic circuit separately measures the powerconsumed in tuning the vibratory instrument, and performing the bonditself. This data is used, together with other parameters, to enable theproduction of a secure and reproducible bond.

Fastening Procedures

Staking

Although the above-discussion emphasizes bonding or welding, the presentinvention also contemplates staking in most situations as an alternativeor supplement. Staking generally involves the mechanical interlock ofdissimilar materials. Staking is the process of melting and reforming apiece, such as a stud, to mechanically lock a material in place. Itprovides an alternative to bonding when two parts to be joined are madeof dissimilar materials that cannot be bonded, or simple mechanicalretention of one part relative to another is adequate.

The advantages of staking include short cycle time, and the ability toperform multiple staking with one end effector. The most common stakingapplication attaches metal to plastic. A hole in a metal part isdesigned to receive a plastic stud. An end effector with a contoured tipcontacts the proximal end of the stud and creates localized frictionalheat. As the stud melts, light pressure from the end effector reformsthe head to the configuration of the end effector. When the end effectorstops vibrating, the plastic solidifies and the metal and plastic partsare fastened together.

For example, a PEEK (or other polymer) anchor/fastener, or tack may beused to couple two materials together, in this case two porous metals.After staking, a proximal end assumes the shape of the end of the endeffector. Additionally, the distal end of the tack is fastened to porousmetal, such as may be found on an interior face of an implant, securedusing vibratory energy.

Initially, the anchor is threaded or otherwise secured to the bone. Apost projecting away from the bone on the proximal end of the anchor canbe used to pierce soft tissue to be attached, holding it in positionrelative to the bone. The tip is then formed into a cap by staking, withor without an interposing element between the soft tissue and the capformed at the proximal end of the post. If needed, the post can betrimmed (either mechanically or by shearing off with vibratory energy)before staking. In this manner, a plate or other structure can beattached using two or more tacks.

Fastening into Existing Cement/Adhesives

In an additional embodiment in accordance with the invention, a fasteneris formed to embed within, and thereby become securely fastened to,previously hardened bone cement, in vivo. This method is advantageouslyemployed, for example, to repair bone fractures, secure and resecureimplants, repair periprosthetic fractures, and to secure or repairdental devices and implants. For example, a medical practitioner mayobserve a lucent line progressively developing as an implant loosens,indicating a separation between body tissue and the implant. In theprior art, revision surgery would be required in order to remove and orre-cement the implant. In accordance with the invention, a tack, pin,bar, rod, plate or other fastener may be inserted into the body, andfastened to cement implanted earlier, through the application ofvibratory energy, said energy advantageously including ultrasonicenergy. As discussed elsewhere, herein, the distal portion of thefastener is caused to resonate and vibrate in contact with the bonecement, locally heating the latter to enable adhesion to the fastener.The fastener thus may serve as an anchor point in subsequent steps tore-secure the implant.

As an anchor point, a fastener thus affixed may alternatively be used tosecure soft tissue, such as a rotator cuff, collateral ligament, orjoint capsule.

Fasteners securable to implanted bone cement include the materialsdescribed in this specification, including as examples PMMA, metal,metal at least partially coated with PMMA or acrylic, PEEK(polyetheretherketone), and acrylic, or can be a composite includingresin, and or carbon fibers. A thin coating of PMMA or acrylic, as smallas several microns, contributes to forming a secure bond with bonecement within the body. Bonds may additionally be formed betweendissimilar adhesives.

An initial bore may be made in the bone cement to aid alignment, totemporarily retain the fastener, or to increase the surface area forfastening. The fastener may be placed in an intended location through,for example, intramedullary, percutaneous, or retrograde approaches.

End Effector for Fastening into Adhesives

Further, the end effector can be used as the implant itself.Specifically, in one embodiment of the invention, a metal pin, screw, orother engagement shape is inserted into a thermoplastic (e.g. PEEK) rod,the pin itself attached to an end effector. The metal pin must be firmlyattached, or formed integrally with the end effector, to avoid creatingarcing and sparks due to metal on metal contact between the pin andeffector. For removable pins, a release mechanism is provided.

In accordance with the invention, an end effector having a distal tipformed or attached thereto is inserted into a medullary canal in a longbone, and affixed into adhesive through the use of vibratory energy, asdescribed in this specification. The end effector is then removed fromthe remainder of the vibratory energy generating device, wherebyconnection means at a proximal end may be used to secure the endeffector within the bone, or to body tissue to be attached, or toanother implant.

Fastening into Implanted Device

Implants, including fastener implants, may be bonded to cementpreviously implanted within the body. Previously implantedintramedullary devices, secured with a substantial amount of adhesive,provided numerous points at which tacks, pins, rods or other fastenermay be attached through the application of vibratory energy, asdescribed herein. These fasteners may then serve as anchoring points fora variety of additional devices, for example plates or bands. Inparticular, where fasteners are affixed on opposing sides of a fracture,a plate may be used to stabilize the fracture, without a requirement forimplanting screws within the bone. In this manner, more invasive orcomplex conventional means of repair, including cerclage, may be used toa lesser extent, or avoided.

An additional embodiment, similar to implantation of an end effector asdescribed above, includes the implantation of a device coated over atleast a portion of its surface with adhesive, or having a roughened orporous surface, or a surface with shaped regions, into or onto which afastener may be affixed as described herein. Once the device isimplanted, it may then serve as a convenient fastening point asdescribed.

Distal Fastening/Retrograde Approach

In accordance with a further embodiment of the invention, vibratoryenergy is applied to cause thermal deformation distal to the site ofapplication of the end effector. In this application, the mechanicaldeformation, especially in dissimilar materials, occurs at a site awayfrom the vibratory horn or end effector. The staking or bonding canoccur not at the trailing edge of the implant, but along the implantsurface or at the far end of the implant where the implant can bemechanically bonded to body tissue, implanted cement, or anotherimplant, particularly if it is a dissimilar implant. In accordance withthe invention, a rough or irregular surface, or at least one surfacecavity into which the fastener may deform, may be used to promote securebonding.

Distal fastening in accordance with the invention is advantageouslyemployed where a retrograde approach is safer or easier than directaccess to a fastening site. In this manner, a fastener may be insertedat a remote location to contact a distant object, the distal end of thefastener being bonded in accordance with the invention, and the proximalend of the fastener being secured by means of the invention, or otherknown means, to secure the distant object within the body. An examplewould include bonding a fastener having distal polymeric material to animplant having a roughened or porous surface, or a surface with a gap oropening forming a shape into which the polymeric material may flow, toharden upon cooling, thereby affixing the fastener to the implantsurface. In this manner, a surface of the implant positioned in fixedcontact with body tissue may be fastened, while an articulating surfacemay remain free of fasteners.

In one embodiment, the retrograde or distally fastened fastener isadditionally connected to an implanted bone augment, or bone graft,thereby providing primary and or secondary stabilization for theaugment. The augment may be implanted, for example, to replace diseasedor damaged bone. In this manner, an articulating surface as well as anadjoining area of bone may be secured by a single fastener, or a seriesof fasteners. The fastener may be distally bonded to both the augmentand the device bearing the articulating surface. The fastener may alsopass through the augment, as through a bore. The augment may be composedof any material or combination of materials suitable for its intendedfunction, including metal, plastic, ceramic, alloys, moldable materialincluding adhesives, as well as porous forms of these materials.

This retrograde approach may be facilitated through the use of acannula, or an expanding cannula, such as is disclosed in U.S. Pat. No.6,814,715, incorporated herein by reference, and related patents citedtherein. Retrograde examples include fastening an acetabular replacementfrom behind the cup, fastening a tibial bearing surface replacement froma point below the bearing surface, and fastening a hip replacementimplant from the femur body or distal end of the femur. Like examplesare contemplated for the smaller analogs of the arm. Retrogradeapproaches may also be used in fastening or repairing bones of thehands, feet, skull, and spine.

It should be understood that in the case of distal fastening, as well asproximal fastening, the fastener body can be advantageously caused toenlargen. The enlargened portion may prevent staked material fromseparating from the fastener. Alternatively, the enlarged portion mayprevent the fastener from dislocating from a target location. Forexample, the enlargened portion may be too large to pass through theportal or opening through which the fastener entered.

The fasteners and fastening methods of the invention are advantageouslyutilized for use in-vivo, reducing or avoiding tissue necrosis byminimizing exposure of tissue to heat, and may be implemented throughreduced size incisions, including keyhole incisions, as may be employedin laparoscopic procedures. Fasteners may additionally be formed andfastened in accordance with the invention in the operating room, at theconvenience of the surgical practitioner, when the exact configurationand dimensions needed are best understood, and thereafter implanted.

Spinal Fixation

Staking in accordance with the invention can be advantageously appliedto a variety of angulated screws, typically used in spinal applications.Specifically, screws that can be placed at an angle through the plateand then staked in place. The screw and plate have a rounded matingsurface, which allows some adjustability in direction. In accordancewith the invention, an end effector is provided sized to matingly engagean angulated screw head, regardless of the angle of the screw headrelative to a supporting structure adjacent the head. The end effectorapplies vibratory energy to bond bondable material of the supportingstructure and or screw head to a mating surface on the supportingstructure or screw head, respectively.

Locking Screw Fastening

In another embodiment of the invention, a metallic polyaxial screw/rodsystem, of the type typically used in spinal surgery, is modified toinclude holes intersecting both the saddle that holds the rod andpedicle screw head, and the locking screw used to maintain the desiredangle of the pedicle screw. Into these holes, a tack is staked or bondedsuch that the material of the tack flows into the threads between thesaddle and locking screw, effectively preventing loosening of thesystem.

Resecuring or Removing an Implant

As described above, vibratory energy, such as ultrasonic energy, is usedto melt or liquify adhesives, including bone cement. In accordance withthe invention, bone cement is melted in situ, whereupon melted cementflows to bridge or fill voids and gaps, the cement thereafter beingallowed to cool in order to thus re-secure a loosened implant.

In one embodiment, a vibratory end effector is provided with a wedge orconically shaped tip, shaped to melt and displace implanted adhesive. Inthis manner, the adhesive is made flowable by the application ofvibratory energy, and is driven by the tip into nearby bone, or theinterstices between body tissue, filling voids or gaps, reengaging thebone to stabilize an attached implant. The end effector and tip couldthen be withdrawn, or alternatively, either or both devices may be leftwithin the body. If the end effector is to be removed, it is decoupledfrom the tip, as by threading or other mechanical interlock.

In another embodiment, a rod having at least one shaped projection, forexample in the form of a blade or leaf, is passed to a distal portion ofa hip implant through a retrograde entry from the distal portion of thefemur. The rod is passed through a space in the body, in this examplethrough an intramedullary canal. To faciliate passage, a boring may beformed beforehand, or the rod may be hollow, for example in the form ofa coring drill. As the rod and blade pass through the intramedullarycanal, the blade is resiliently or mechanically maintained in adirection substantially parallel to the passage. Once the implantedadhesive is encountered, vibratory energy is transmitted through the rodto cause the blade to vibrate, and thereby melt adhesive proximate theimplant. When sufficient adhesive is melted or liquified, the blade maybe advanced, until a desired length of blade has been admitted.Subsequently, the rod bearing the blade may be rotated, therebyliquefying a perimeter of adhesive.

If it is desired to re-secure the implant, the blade may be withdrawnonce the implant has been repositioned, if desired, and the void or gapof concern has been re-filled with melted adhesive. Alternatively, if itis desired to remove the implant, removal is accomplished before theadhesive resolidifies, such as by lifting the implant away from theadhesive, out of its current location. Multiple blades may be employedto reduce the time required to complete the removal or resecuringprocess.

Alternative shaped projections include cups, cones, wires, or othershapes which may pass through the body to the area where the adhesive islocated, and which are advantageously formed to best fit the geometry ofthe adhered interface, to carry out the functions previously described.

In an alternative embodiment, the rod and blades are left within thebody, embedded in the resolidified cement, to operate as a reinforcementand or attachment point for further fasteners or implants, includingarthroplasty components and prosthetics, or testing or reportingapparatus attached to or embedded within the device. As an attachmentpoint, the rod may be provided with bores or apertures, which may bethreaded, into which other fasteners may be inserted, and optionallyfurther fastened in accordance with the methods disclosed herein.

In an alternative embodiment, the shaped projection is formed of, orcoated with, a bondable material, for example a polymer, which is thenbonded to a roughened or porous surface, either in the operating room,or in the body. Within the body, the surface may be that of existing orimplanted bone, or that of a previously or recently positioned implant.When the shaped surface is positioned in contact with the roughenedsurface, for example an intramedullary rod having a porous metalsurface, vibratory energy is passed to the shaped projection to causethe projection to melt and bond to the roughened surface.

The issue of implant removal after bonding or staking of one or moreimplants is one that needs to be addressed if the clinical situationdictates. In accordance with one embodiment of the invention, a modifiedend effector for use with vibratory energy forms an implant removaltool. One end engages alternately a vibratory generator, andsubsequently a t-handle. The other end of the end effector is providedwith surface asperities, or is otherwise roughened to enhance engagementto the implant or material to be removed. In use, vibratory energy isactivated to drive end effector around an implant to be removed, firmlybonding the end effector to the implant. The t-handle is then connected,and through a repeated rocking or oscillating motion of the t-handle,the bond or weld is broken and the implant may be removed.

Fastening Dissimilar Materials

It should be understood that a proximal or distal polymer to polymerconnection may be made through the application of heat or vibratoryenergy, such as ultrasonic energy, as described herein. In this manner,fastener containing polymer may be connected to a roughened, porous orshaped surface, or to another polymeric fastener, or polymeric coatingon an implant or implanted fastener. For example, an arthroplasty orprosthetic component may be at least partly covered with polymer, thepolymeric surface exposed to an intended site for fastening. Moreover, aplurality of arthroplasty components may include polymeric or heatsoftenable material, the components being thus fastenable together inaccordance with the invention.

An advantage to a polymeric containing, or polymeric coated fastener orimplant is the ability to incorporate one or more therapeutic substanceswithin the coating, whereupon the therapeutic substance may elute, orrelease the therapeutic substance in-vivo over time, in a predictableand useful manner. U.S. Provisional Patent Application No. 60/728,206,entitled “Drug Eluting Implant” and incorporated herein by reference,provides examples of means for delivering therapeutic agents, althoughthose skilled in the art will appreciate that other known methods may beadvantageously employed in combination with the invention.

Fastening Combinations and Applications

The fastening devices of this and other embodiments of the invention maybe used in combination with fasteners in the prior art. The fasteningand repair of tissue or an implant may be performed in connection withsurgery of a joint, bone, muscle, ligament, tendon, cartilage, capsule,organ, skin, nerve, vessel, or other body parts. For example, tissue maybe repaired during intervertebral disc surgery, knee surgery, hipsurgery, organ transplant surgery, bariatric surgery, spinal surgery,anterior cruciate ligament (ACL) surgery, tendon-ligament surgery,rotator cuff surgery, capsule repair surgery, fractured bone surgery,pelvic fracture surgery, avulsion fragment surgery, shoulder surgery,hernia repair surgery, and surgery of an intrasubstance ligament tear,annulus fibrosis, fascia lata, flexor tendons, etc.

Focal Defect Correction

In accordance with the invention, areas of disease or trauma arereplaced with an implant or graft, secured in situ using vibratoryenergy. In this manner, healthy tissue may remain undisturbed, and afocal defect corrected. Examples include replacing a portion of anarticulating surface, such as a condyle, the acetabulum, or glenoidfossa, or replacing portions of bone or soft tissue that have beendamaged by injury or disease.

The diseased area may be replaced by implanted tissue, including bonefragments or compressed living tissue, fabricated non-living materialsuch as polymers or metal, or any other material a medical practitionerdeems best. An interface is created between the graft and the body, andincludes a quantity of bondable material there between. Advantageously,if the implant is not made entirely from bondable material, a surface ofthe implant contacting the bondable material of the interface isprovided with a roughened or porous surface, or a surface with one ormore cavities into or onto which heat softened or melted material mayflow and thereby lock onto once cooled, hereafter an irregular surface.Further, the body tissue may be treated to have an irregular surface forthe same purpose. In addition, an implant may be attached to the bodytissue using methods or devices of the invention, or alternativelyscrews, adhesives, or any other known means, the implant provided withan irregular surface.

Thus, once the implanted material is in place, an interface defines astrata that includes body tissue having an irregular surface, or animplant attached to the body tissue, the implant having an irregularsurface, bondable material, and implant material having an irregularsurface, unless the implant is provided with bondable material at theinterface.

Vibratory energy is applied proximate the interface, operative to causethe bondable material within the interface to soften or melt, therebylocking onto the irregular surface of both the body tissue orintervening implant on one side, and the implanted material on anotherside, whereby the implanted material is firmly attached to the body oncethe bondable material has cooled.

Chain of Fastening

The invention specifically contemplates a chain of fastening from boneto implant to tissue. For example, bone cement is fastened to bone, animplant is fastened to the bone cement as described herein, tissue isstaked or fastened to the implant, and the end of the implant is cappedor secured as described herein and in the incorporated references.Fasteners may alternatively be bonded to bone using methods describedand illustrated herein and described in the incorporated references, andimplants or tissue are fastened to the fastener bonded to bone, usingthe methods and devices of the invention.

It is contemplated that the devices and methods of the present inventionbe applied using minimally invasive incisions and techniques to fasten,for example, muscles, tendons, ligaments, bones, nerves, and bloodvessels. A small incision(s) may be made adjacent the damaged tissuearea to be repaired, and a tube, delivery catheter, sheath, cannula, orexpandable cannula may be used to perform the methods of the presentinvention. In addition to using a cannula with the present invention, anintroducer may be utilized to position implants at a specific locationwithin the body.

The methods of the present invention may further be performed underindirect visualization, such as endoscopic guidance, computer assistednavigation, magnetic resonance imaging, CT scan, ultrasound,fluoroscopy, X-ray, or other suitable visualization technique. Theimplants, fasteners, fastener assemblies, and sutures of the presentinvention may include a radiopaque material for enhancing indirectvisualization. The use of these visualization means along with minimallyinvasive surgery techniques permits physicians to accurately and rapidlyrepair, reconstruct, augment, and secure tissue or an implant within thebody.

DETAILED DESCRIPTION

As detailed below, the invention provides for stabilization of implantsor body structures, including fastening of a chain of implants. Theinvention additionally relates to removing implants fastened withbondable materials using vibratory energy, including for exampleultrasonic energy. The invention further provides for locking similar ordissimilar materials together in the body by providing a surface betweenelements that is roughened or porous, or which has one or more cavitiesor projections upon which melted material may form and lock to oncecooled. Additionally disclosed are devices for generating andcontrolling vibratory delivery, and mixing materials using vibratoryenergy.

The methods and devices disclosed herein may be used in conjunction withany surgical procedure of the body. The fastening and repair of tissueor an implant may be performed in connection with surgery of a joint,bone, muscle, ligament, tendon, cartilage, capsule, organ, skin, nerve,vessel, or other body parts. For example, tissue may be repaired duringintervertebral disc surgery, knee surgery, hip surgery, organ transplantsurgery, bariatric surgery, spinal surgery, anterior cruciate ligament(ACL) surgery, tendon-ligament surgery, rotator cuff surgery, capsulerepair surgery, fractured bone surgery, pelvic fracture surgery,avulsion fragment surgery, shoulder surgery, hernia repair surgery, andsurgery of an intrasubstance ligament tear, annulus fibrosis, fascialata, flexor tendons, etc.

Also, an implant may be inserted within the body and fastened to tissuewith the present invention. Such implant insertion procedures include,but are not limited to, partial or total knee replacement surgery, hipreplacement surgery, shoulder replacement surgery, bone fasteningsurgery, etc. The implant may be an organ, partial organ grafts, tissuegraft material (autogenic, allogenic, xenogenic, or synthetic),collagen, a malleable implant like a sponge, mesh, bag/sac/pouch,collagen, or gelatin, or a rigid implant made of metal, polymer,composite, or ceramic. Other implants include breast implants,biodegradable plates, porcine or bovine patches, metallic fasteners,compliant bearing for medial compartment of the knee, nucleus pulposusprosthetic, stent, suture, suture anchor, tissue graft, tissue scaffold,biodegradable collagen scaffold, and polymeric or other biocompatiblescaffold. The scaffold may include fetal cells, stem cells, embryoniccells, enzymes, and proteins.

Fastening Materials

The trauma bonding and staking system and other embodiments of thepresent invention contemplates the use of any biocompatible materialbondable and/or stakable within the human body. The materials used mayinclude, but are not limited to, degradable, biodegradable, bioerodible,bioabsorbable, mechanically expandable, hydrophilic, bendable,deformable, malleable, riveting, threaded, toggling, barded, bubbled,laminated, coated, blocking, pneumatic, one-piece, multi-component,solid, hollow, polygon-shaped, pointed, self-introducing, andcombinations thereof. Also, the devices may include, but are not limitedto, metallic material, polymeric material, ceramic material, compositematerial, body tissue, synthetic tissue, hydrophilic material,expandable material, compressible material, bondable material, andcombinations thereof.

Preferably, this material can melt with the application of energy,becoming gel-like, tacky, or soft. The energy source and the techniqueused to bond and/or stake the material within the body can be selectedto minimize or avoid damage to surrounding body tissue. Exemplarymaterials that may be used may include polymers, ceramics, composites,and metals, although other materials may also be suitable for use withthe invention. While the present invention contemplates the use of anyof these materials in any of the following embodiments, polymericmaterial is used in the following examples and description simply toillustrate how the invention may be used.

Generally, there are two types of polymers: thermoset and thermoplastic.Thermoplastics may be used with the present invention because they canbe softened, reheated, molded and remolded. Thermoplastics are generallyclassified as either amorphous or semi crystalline. Some semicrystalline polymers have some amorphous structure while other semicrystalline polymers may be more crystalline than others. Examples ofamorphous polymers are poly carbonate (LEXAN), polystyrene, polysulfone(ULDALL), and acrylics polycarbonate (ABS and styrenes). Examples ofsemi crystalline polymers include acetyl (DELRIN), nylon, polyester,polyethylene, polyether ether ketone, poly propylene, polyvinylchloride(PVC), and Caprolactam. Biodegradable semi crystalline polymers mayinclude polylactic acid and polyglycolic acid. Copolymers of PGA and PLAmay also be used. These copolymers may vibratory bond or stake betterthan pure PGA and PLA. Other polymers which may be used with the presentinvention, either as a thermoplastic or non-thermoplastic, arepolyethylene glycol (PEG)-copolymers and D,L-lactide-co-glycolidepolyesters.

Some semi crystalline materials have an amorphous structure or anamorphous region within them. These materials are particularly suitablefor surgical bonding and/or staking, especially vibratory bonding andstaking. Examples of such materials include PAEK (polyaryletherketone),including PEEK (polyetheretherketone) and PEKK (polyetherketoneketone).With these special semi crystalline materials, the amorphous content ofthe polymer makes the material more conducive to vibratory energy, andtherefore a better bond or mechanical interlock is achieved. Also, alower amount of energy is needed for these materials.

The semi crystalline materials without an amorphous structure or regionhave a rigid or fixed melting point. A high level of energy is requiredto breakdown the crystalline structure before the melting occurs. Oncethe melting starts, the material very rapidly moves through thetransition area from a solid to a flowable substance, i.e. a liquid.Also, the molecular structure of semi crystalline materials absorbsvibrational energy making it more difficult to transmit the vibrationalenergy from an energy-producing instrument to the interface of the partsbeing joined. For example, polylactic acid reaches its melting point andgoes through its transition region rapidly which causes it to flow inthe tissue. This rapid heating and complete, or nearly complete, meltingof the material weakens the overall structure and causes tissuenecrosis. When this material is used in surgical screws, plates, rods,etc., care must be taken to avoid over melting and weakening of theimplant. The temperature, time, and pressure must be closely monitoredand controlled with semi crystalline materials or the implant will fail.

The polymers used in the present invention, such as PEEK and PLLA, haverandomly arranged molecules allowing vibrational energy to pass throughthe material with little attenuation. As such, the material requiresrelatively little vibratory energy to make the material soften andbecome tacky. This small amount of energy or heat needed to bond orstake PEEK and PLLA helps avoid or minimize the likelihood of tissuenecrosis. In fact, temperature measurements with PEEK show that thesurface of the material, a distance away from the immediate bondinginterface, does not exceed 37° C., and that the temperature profiletrails back to ambient within 30 seconds or less, suggesting quickenergy dissipation. With PLLA, temperature elevation of the surface islimited to 33° C. With these materials, the transition period is longerin duration and therefore, when applying energy, the material graduallysoftens, passing from a rigid state through a transition state to arubbery state and then to a flowable gel-like state. The amorphousfeatures of these materials make them vibratory bondable and stakablewith lower temperature and better bonding points. To bond or stake thesematerials, the true melting point does not need to be reached orexceeded except at a limited area at the immediate bonding interface, sothere is less risk to surrounding body tissue. PEEK and PLLA are alsouseful with the system of the present invention because it has a modulusof elasticity very close to bone.

The temperature, time, pressure, and other parameters of the energyprocess may be closely monitored and controlled to achieve an effectivebond or staking. Also, because the material does not substantially melt(only a limited region softens and becomes tacky) the holding strengthof the thermoplastic during and after application of the energy is notjeopardized. That is, a fastener made of a thermoplastic which melts,like those in the prior art, cannot maintain a compressive force againsta component or implant during the bonding or staking process. This isbecause the material of the fastener becomes liquefied, and a fastenerin liquid form cannot maintain a compressive or tension force. Thepresent invention contemplates implants made of PHA, PEEK or PLLA whichbond by softening or making tacky the polymer material at the bondingregion. The remaining PHA, PEEK or PLLA material does not flow andtherefore retains its ability to maintain a compression or tensionforce.

When bonding two thermoplastic components together, it is optimal thatthe components be chemically compatible to create a molecular bond.Similar thermoplastics may be compatible if their melt temperature iswithin about 6 degrees Celsius or if they have similar molecularstructures. Generally, amorphous polymers may be bonded to each other.In the present invention, PEEK may be bonded to PEEK. Biodegradablepolymers may be bonded to biodegradable polymers. Biostable polymers maybe bonded to biostable polymers. Biodegradable polymers may be bonded tobiostable polymers.

Sulfonation

Polymers used in methods and devices of the invention may be sulfonatedto be wettable, or hydrophilic, using any of a variety of known methods,including a method of exposure to sulfur dioxide, an oxygen donatinggas, and a free radical producing energy, as described in U.S. Pat. No.6,066,286, the contents of which are hereby incorporated herein byreference. A hydrophilic surface presents the opportunity for improvedbiointegration of implanted devices, including an enhanced surfacestructure for tissue ingrowth, should that be an objective. Moreover,therapeutic substances may be readily incorporated into the sulfonatedsurface layer, and may more readily transfer a target therapeutic doseinto the body. Through sulfonation of bioabsorbable polymers, fastenersmay be formed to elute therapeutic substances, with the aforementioneddesirable benefits.

Further, a wettable surface may be used to reduce friction on one ormore bearing surfaces, such as articulating bearing surfaces in joints,creating a more optimal and longer lasting replacement or repair. Thewettable surface can be inlaid into the bone surface, including aninlaid articular surface. One mechanism of operation for the implantcontaining hydrophilic materials is the formation of a molecular linkagewith body fluid, thereby promoting lubrication, tissue ingrowth, andbiocompatibility. It is further possible to make a device surfacehydrophobic using sulfonation.

In one embodiment of the invention, a sulfonated surface improvesbonding and tissue ingrowth with biological tissue introduced after thesurface has been sulfonated.

Sulfonation may be used to alter an inherent characteristic of amaterial, for example making a non-wettable surface wettable, useful,for example, with certain polymers, including but not limited topolyurethane, polyethylene, polyglactic acid, or polylactic acid.

In another embodiment in accordance with the invention, any of thedevices of the invention may be provided with a sulfonated surface, orfabricated using sulfonation, thereby conferring additional beneficialproperties to the device. For example, the stents of FIGS. 91-92, or themesh of FIG. 93, may be constructed using sulfonation, rendering thedevice less likely to cause thrombosis. Sulfonation may be used in avariety of ways to produce this benefit. In particular, the surface maybe made more wettable, and thus smoother or more slippery.Alternatively, the surface may be treated with sulfonation to promoteincorporation of antithrombotic therapeutic substances, for exampleHeparin, which may be released upon implantation, or gradually overtime. In another alternative, the implanted device may be fabricatedfrom two materials, for example a polymer and a metal, which are bondedtogether using sulfonation.

Specifically, sulfonation may be used to cause the deposition of a thinlayer of metal upon a polymeric core or form. This form of metal platingmay render the device harder, smoother, more biocompatible, moredurable, magnetic, more receptive to wave energy, and thus heatable, ormay be used to impart any other property for which metal is employedwithin the body. A harder, smoother surface is particularly advantageousfor an articulating or load bearing surface, such as a joint. Forexample, a coating of cobalt chrome is plated only to the condylarsurface areas of a polymeric femoral implant, thus reducing both weightand cost.

Conversely, sulfonation may be used to improve bonding of a polymer to ametallic core or form, in order to confer the metallic form with theproperties of a polymer, as described further herein, and in theincorporated references.

Sulfonation is particularly advantageous for combining therapeuticsubstances and devices, because significant quantities may be associatedwith the surface of the device without the use of heat, pressure, and ortime, which could have an adverse effect on the device, or on thetherapeutic substance.

Metals

In accordance with the invention, metals are advantageously connectedwith fasteners incorporating polymeric materials. Any of a variety ofmetals may be used, either smooth or formed with at least portions offoam metal, or a roughened or porous surface, or formed with cavities orother shapes upon which polymeric material may mold, enter, adhere, orotherwise affix. The polymer is softened in accordance with theinvention through the application of heat, including heat created usingvibratory energy, to become tacky, or sufficiently softened in order tobond on a microscopic level, or a macroscopic level through adaptationto the surface structure of the metal. For use in vivo, biocompatiblemetals are used, including stainless steel, nitinol or other SMA (shapemetal alloy), tantalum, porous tantalum, titanium, cobalt-chrome alloys,and other metals such as are known to those skilled in the art.Additional related information, including bonding polymers and metals,and polymer to polymer bonding of implant materials, may be found inU.S. Pat. No. 5,163,960 entitled “Surgical devices assembled usingbondable materials”, and U.S. Pat. No. 7,104,996 entitled “Method ofperforming surgery”, the contents of each of which being incorporatedherein by reference.

Therapeutic Substances

The fastening device of the present invention may include therapeuticsubstances to promote healing. These substances could includeantibiotics, hydroxypatite, anti-inflammatory agents, steroids,antibiotics, analgesic agents, chemotherapeutic agents, bonemorphogenetic protein (BMP), demineralized bone matrix, collagen, growthfactors, autogenetic bone marrow, progenitor cells, calcium sulfate,immo suppressants, fibrin, osteoinductive materials, apatitecompositions, germicides, fetal cells, stem cells, enzymes, proteins,hormones, cell therapy substances, gene therapy substances, andcombinations thereof. These therapeutic substances may be combined withthe materials used to make the device. Alternatively, the therapeuticsubstances may be impregnated or coated on the device. Time-releasedtherapeutic substances and drugs may also be incorporated into or coatedon the surface of the device. The therapeutic substances may also beplaced in a bioabsorbable, degradable, or biodegradable polymer layer orlayers.

The therapeutic agents may also be placed within one or more cavitiesdisposed in a fastening device of the present invention. Differentagents may be disposed in different cavities of the device tospecifically tailor the implant for a particular patient. Dosages of thetherapeutic agent may be the same or different within each of cavitiesas well. The cavities may include a cover which may release the agent ina controlled or timed manner. The cover may be biodegradable orbioerodible to allow the agent to release to surrounding tissue.Examples of suitable therapeutic agents include bone growth inducingmaterial, bone morphogenic proteins, osteoinductive materials, apatitecompositions with collagen, demineralized bone powder, or any agentpreviously listed. U.S. Provisional Patent Application No. 60/728,206entitled “Drug Eluting Implant” discloses means for deliveringtherapeutic agents. The above-mentioned provisional application isincorporated by reference herein in its entirety.

The fastening devices of this and other embodiments of the invention maybe used in combination with fasteners in the prior art. Examples offasteners, implants, and their methods of employment may be found inU.S. Pat. Nos. 5,163,960; 5,403,348; 5,441,538; 5,464,426; 5,549,630;5,593,425; 5,713,921; 5,718,717; 5,782,862; 5,814,072; 5,814,073;5,845,645; 5,921,986; 5,948,002; 6,010,525; 6,045,551; 6,086,593;6,099,531; 6,159,234; 6,368,343; 6,447,516; 6,475,230; 6,592,609;6,635,073; and 6,719,765. Other fastener types are disclosed in U.S.patent application Ser. Nos. 10/102,413; 10/228,855; 10/779,978;10/780,444; and Ser. No. 10/797,685. The above cited patents and patentapplications are hereby incorporated by reference in their entirety.

Naturally Occurring Materials

In addition to PEEK and the other polymers described herein, theimplants, devices, and methods of the present invention may use keratin,a naturally occurring polymer. Keratin may be vibratory bonded or stakedto itself, to other implants, or within tissue. This may be performed inthe operating room or intracorporeally. Keratin may be bonded tocollagen or to other known polymers. In an exemplary application,keratin may be used to fasten tissue to bone since keratin has BMP andtissue scaffold properties. It is contemplated that any of devices andmethods disclosed herein may utilize keratin alone or in combinationwith PEEK, polylactic acid, or other polymer. Keratin may be used tomake fasteners, disc replacements, joint replacement components, stents,cell scaffolds, drug reservoirs, etc. Also, joint bearing surfaces mayinclude keratin with or without collagen or chondrocytes. The bearingsurfaces may be fastened to a joint component using PEEK or PLAfasteners.

Another polymer that can be used with the present invention is a classof natural materials, called polyhydroxyalkanoates- or PHA polymers.These polymers are synthesized in nature by numerous microorganisms, andthey have been recently recognized as the fifth class of naturallyoccurring biopolymers (along with the polyamino acids, polynucleicacids, polysaccharides, and polyisoprenoids). Unlike the other naturallyoccurring biological polymers, however, the PHA polymers arethermoplastic, i.e. they can be repeatedly softened with heat andhardened with cooling. As such, these polymers can be processed muchlike the plastics we use today. A specific example of a PHA polymer thatcould be used is poly-4-hydroxybutyrate material. Such PHA polymers areavailable from Tepha Inc of Lexington, Mass.

Polymethylmethacrylate

Fasteners of the invention may be coated with polymethylmethacrylate(PMMA), in order to promote bonding with PMMA used in the body, or PMMAcould be incorporated into polymer of the fastener, or deposited withincavities or shapes formed in the fastener surface, including threaded,roughened, porous, or nano textures. A fastener may be thus coated withPMMA, or formed entirely of PMMA, and may be heat bonded, advantageouslyusing ultrasound, to another PMMA surface or other adhesive surface,otherwise as described herein with respect to bone cement.

Although PMMA, known generally as bone cement, and other polymers mayfunction more as a grouting agent than a cement or adhesive, only theterm “adhesive” is used throughout the specification for simplicity.

Vibratory Mixing

With reference to FIG. 58, vibratory energy is used to mix materials2104, for example materials to be used in formulating implants of theinvention, adhesives and cements, therapeutic materials and othersubstances to be incorporated into implants, materials to be implantedwithin the body, or materials to be used during a medical procedure.

Materials 2104 may be mixed in a production or laboratory setting, or inthe operating room immediately before implantation. A mixer 2108 appliesvibratory energy to materials 2104, and includes a horn 2100, a mixingbowl or chamber 2102, and optionally a supporting member 2106. Vibratoryenergy may be applied directly to chamber 2102, or may be applied tosupporting member 2104, as illustrated, in order to promote evendistribution of materials 2104, possibly including the release of gases,gaps and voids, and resulting in a denser and or more even mixture. Inaddition, the temperature or pressure of chamber 2102 or mixture 2104,as well as other parameters, may be controlled by means known in theart, along with the application of vibratory energy, including forexample ultrasonic energy, to produce an optimal resulting mixture 2104after processing.

To improve mixing, the energy level and frequency may be tailored to theparticular mix constituents. For example, low energy or longerwavelengths may be used for polymeric materials mixing, particularlyamorphous polymers, and shorter wavelengths may be advantageously usedfor metallic materials and denser polymers, and PMMA. Other frequenciesmay be used, both lower and higher than the frequencies commonly used inultrasonics, for example within the audible range, or in the megahertzrange.

Polymer or adhesive, including bone cement, may be maintained orconverted to a liquid or viscous form within mixer 2108. Additionally,therapeutic substances, including pharmaceuticals, may optionally beadmixed. Further, an implant 2110 may be dipped into the material 2104within chamber 2102 in order to be coated by material 2104. The dippedimplant 2110 can include any material to be implanted, including metalsand polymers, including porous metal or material with pores, cavities ora roughened surface, wherein material 2104 enters the pores or cavitiesin order to produce a stronger bond, and to increase the amount ofmaterial of the coating. It is advantageous for the dipped implant tomaintain its shape until the coated polymer cools and hardens, if thepolymer is heated.

In this manner, an implant such as a stent or arthroplasty component,for example implant 2110, may be coated to elute a therapeuticsubstance, while maintaining appropriate physical dimensions andproperties. Further or alternatively, the coated implant may then befastened within the body using the methods and devices described herein,the coating forming a substrate for proximal and or distal heatfastening, including vibratory fastening. Vibratory energy imparted tothe mixing chamber during coating further serves to improveinterdigitation and a close, conforming coating of the implant.

Vibratory mixing as described, advantageously combined with changes inmixing parameters, such as temperature and pressure, may be used toalter the polymerization characteristics of material 2104, for example,polymers within mixing chamber 2102. Accordingly, the resultant polymermay have properties best suited to the procedure contemplated.Properties affected may vary, but may include changes in density,porosity, flexibility, hardness, color, and smoothness.

Manufacturing with Vibratory Energy

With reference to FIG. 58A, in addition to mixing, as described herein,vibratory energy may be advantageously employed in manufacturingrequiring a mixing step. Operating parameters such as temperature andpressure may be varied, in combination with the application of vibratoryenergy to mixing or staging apparatus. With respect to injectionmolding, in particular, vibratory energy is applied to any or all of thehoppers 2122, rams 2124, ejectors 2126, gates, sprues or runners 2128,and cavities and cores 2130 during the injection process. Vibratoryhorns 2100 are illustrated, connected to a source of vibratory energy(not shown) as known in the art, of sufficient power to achieve adesired affect, which may include for example improved mixing, improvedflow, more uniform filling, more efficient ejection, faster injection,preheating of injected material, and increased compaction of moldedmaterial. With respect to injection molding, in particular, vibratoryenergy is applied to any or all of the gates, sprues, runners, cavitiesand cores during the injection process. In this manner, it is possibleto increase the density and uniformity of the molded product, as well asto improve fracture resistance and performance of the part both duringthe fabrication process, and after fabrication.

Vibratory mixing and packing of the invention is particularly useful inmold filling and fabrication of precision parts requiring a tortuousfill path, having delicate structures, or having features on thenanometer scale.

In an additional manufacturing application, a biologic matrix includingfibers, such as collagen fibers, can be more uniformly mixed and formedinto a polymer or biologic collagen scaffold in combination withvibratory energy as described. The matrix may include cells orpharmaceutical agents, including chemotherapeutic agents, antibiotics,cell growth agents, growth inducing factors, and proteins. Moreover,manufactured or harvesting tissue, cells, or cell products may beintegrated into a mixture that is molded to conform to a body surface orcavity, including epithelial surfaces, or to an implant. Manufacturingmay take place, for example, in a factory, laboratory, operating room,outpatient facility, or medical office.

It should be understood that vibratory energy selected from a wide rangeof frequencies may be used to improve injection molding, for examplevibration within the audible range, including vibratory energy of lowerthan 1 kHz, for example 0.3 kHz.

Bonding Parts

Referring now to FIG. 59, when bonding parts with adhesive, it can be achallenge to evenly distribute grouting agent or adhesive between theparts to be fastened. In accordance with the invention, vibratoryenergy, for example vibratory energy, is applied to either or bothparts, and or the adhesive layer, to promote movement of the adhesivethroughout the interstitial space 2142 between the parts, whereby a moreuniform, reliable and predictable bond is formed.

With further reference to FIG. 59, in a medical context, it is oftennecessary to use an adhesive or grouting agent, for example PMMA or bonecement 2140, to secure an implant, particularly an arthroplastycomponent, such as tibial arthroplasty component 1400A, within the body.Implant 1400A has a projection or keel portion 1422A which enters aspace within the body, for example the medullary canal of a bone 1402,or implant 1400A may simply lie upon the surface of body tissue. Ineither application, it is advantageous to create uniform contact ininterstices 2140 between the implant, adhesive, and body tissue, inorder to avoid the formation of gaps or voids, which may appear aslucencies in radiography.

In accordance with the invention, vibratory energy, advantageouslyvibratory energy, is applied to an implant, body tissue, or adhesivelayer, for example implant 1400A, bone 1402, and adhesive layer 2140, ora combination of same, to improve movement of adhesive 2410 throughoutthe interface between the implant and the body tissue to be adhered. InFIG. 59, horn 2100 contacts component 1400A, connected to a vibratoryenergy generator (not shown). Alternatively, horn 2100 may contact thebone, or another portion of the implant 1400A. Vibratory energy isadvantageously combined with pressure, applied to the interface, as byapplying pressure to push the implant against a bone surface. An exampleincludes application of force to an upper surface 2144 of tibial insert1400A in the direction of Arrow “A”, which includes insertion of animplant stem 1422A into the tibial medullary canal of bone 1402.Vibratory energy is applied to the upper portion of the tibial implant,for example near or on the bearing surface, or along the sides of theimplant, as the stem is inserted into the canal. Vibratory energy may becontinued for a period of time thereafter, until an even distribution ofadhesive 2140 is achieved. In this example, adhesive enters the smallcancellous bone interstices, as well as surface formations, including aroughened or porous implant surface, or an implant surface with one ormore cavities, to improve the bond between the implant and the body.

Tissue Harvesting

In accordance with the invention, tissue is harvested by placing aharvesting tool with a holding area or chamber, such as a hollow coringdrill, upon or within body tissue and applying vibratory energy to theharvesting tool, tissue, or both. Vibration, such as vibratoryvibration, is applied to cause cells to become dislodged, freely mobile,or movable, whereupon they may be collected in the holding area. Cellsmay be further removed by applying lavage, pressure, suction, orabrasion. In a reverse process, vibratory energy aids in theimplantation of cells, through modification of the body tissue surface,rendering the surface more conducive to implantation, and improvestransfer of cells from the holding area to the implantation site. Theuse of vibratory energy is advantageously applied in the harvesting orimplantation of fetal cells, for example.

The application of heat or other environmental change, or the additionof therapeutic elements, may be used to improve performance ofharvesting or implantation. For example, including injectible polymersmay improve bonding, the addition of nutrients may improve cellviability, or the addition of pharmaceutical agents may improvecompatibility.

Fasteners

Fasteners of the invention may be configured to matingly engage otherimplants, being urged or locked into an advantageous orientation througha molded or otherwise formed three dimensional configuration.Alternatively, fasteners of the invention may be formed to maximizebonding surface, or to modify strength in designated locations.

Staking Fasteners

With reference to FIGS. 45 and 45A-C, in another embodiment of theinvention, a tackable fastener 1100 is sized to be insertable through astab wound, drilled portal, or other focused aperture. The body 1102 ofthe fastener is provided with a passageway or aperture 1104 throughwhich another fastener may pass, for example a suture, cable, or anothersimilar fastener. Fastener 1100 is further provided with a ramped orangled face 1106 which advantageously is provided with a constricted orpointed proximal end 1108, operative to pierce material to be held 1118thereon. The distal end 1110 of the fastener may be secure using thedistal fastening method described in this specification, oralternatively by any known means, including a press fit into a bore,attachment using the aperture described above, or adhesive. Distal end1110 may be provided with a roughened or porous surface to promotesecure attachment by adhesive. If materials are to be held on thefastener, they are passed over proximal end 1108, being pierced by thefastener if needed, and are optionally followed by a load spreadingmember, such as a plate or washer 1112. When all materials are held, acap 1114 is formed on or placed upon the proximal end of the fastener,as described in this specification, and the materials are staked. InFIG. 45, an end effector or horn, for example end effector 104 and horn120D, are applied to fastener 1102 at proximal end 1108, and upon theapplication of vibratory energy, melt and curl over sides 1116, thusforming cap 1114. In the example shown, pin 106 of end effector 104enters bore or aperture 1118 at proximal end 1108, thus establishing andmaintaining alignment with horn 120D at least before and during theapplication of vibratory energy.

Referring now to FIG. 45C, fastener 1120 is formed of at least twodissimilar materials, for example two materials 1122 and 1124 havingdifferent melting points. In the example shown, a proximal end 1108 isadvantageously formed of a bondable material 1124 that may be formedusing the proximal application of vibratory energy, as described above.

Distal end 1110 is advantageously fabricated with a material 1122 havinga higher melting point than material 1124, and may include, for example,metal, ceramic, or a high molecular weight polymer with a higher meltingpoint than material 1122, and may be driven into adhesive or polymer invivo using a distal fastening method of the invention, or using othermeans of attachment. For example, first end 1122 may be press fit,adhered, or threaded onto another fastener.

The dissimilar materials are joined through any known means, such asextrusion, molding, press fit, threading, and adhesion. Mating segments1126 and 1128 may be provided to promote a strong bond between theproximal and distal ends 1108 and 1110.

Embedded Bone Cement Fastener

With reference to FIGS. 32-34, anchors or embedding fasteners 800 may beembedded within previously solidified bone bondable material 802, forexample PMMA or other acrylic based adhesive. In an embodiment inaccordance with the invention, embedding fastener 800 is connected toend effector 804 of a vibratory energy generator 100, such as the typeshown in FIG. 1. Embedding fastener 800 is adapted to enter and engageadhesive or bondable material 802 that has been locally melted byvibratory energy, through contact between embedding fastener 800 andbondable material 802 during operation of generator 100. Embeddingfastener 800 is securely retained by bondable material 802 once thelatter has cooled and hardened.

End effector 804 may be provided in any of a variety of shapes, oneexample being an elongated rod or shaft such as is shown in FIGS. 32-34,connectable to a hand piece at a proximal end 806, and operative totransmit vibratory vibratory energy at a distal end 808. While a rodshape is shown and selected for reduced manufacturing cost, end effector804 may have the form of box or hex channel, oval or other shape,provided it communicates vibratory energy to a distal end portion, or toan attached fastener. Embedding fastener 800 is adapted to connect todistal end 808 of end effector 804 by mechanical interlocking, as by abore 810 in embedding fastener 800, sized to receive a post 812 on endeffector 804, optionally provided with internal or external threading(not shown), wherein post 812 has mating threads. Similarly, a bore oraperture may be provided in end effector 804, matable with a post orprojection on embedding fastener 800. Other mechanical connections arecontemplated, including twist lock configurations, friction fitting, oradhesive attachment. The mechanical connection must be operative,however, to communicate vibratory energy from end effector 804 toembedding fastener 800, as by a firm mechanical connection.

Embedding fastener 800 is adapted to be securely retained withinadhesive 802, in one embodiment, by being provided with a shaped orcontoured surface 814 upon which the adhesive may grip, once hardened. Aroughened or porous surface (not shown) may be provided alone or incombination with shaped surface 814, the adhesive obtaining improvedpurchase thereupon.

Embedding fastener 800 may further be provided with a taper 816 at aleading end 818, which first enters the adhesive, as shown in FIG. 32A.Taper 816 may improves performance, for example, by promoting accuratetracking and movement of embedding fastener 800 into bondable material802, piercing body tissue, and facilitating initial melting byconcentrating vibratory energy over a smaller surface region.

Embedding fastener 800 may be provided with channels 820 operative toprovide a path for molten cement 822 to be displaced, providing room forentry of embedding fastener 800. Where embedding fastener 800 is todisplace a substantial amount of material, channels may be extendedalong the entire length of embedding fastener 800, and may furtherextend along end effector 804, as shown for channel 824 in FIG. 34.Channels 820 are further operative to reduce the possibility of rotationof fastener 800 within bondable material 802. Channels 820 are thusdisposed to extend into bondable material 802 after insertion, and mayextend to the face of embedding fastener 800. Channels 820 areadditionally illustrated on embeddable end effector 3054 in FIG. 84.

Once anchored, end effector 804 and embedding fastener 800, embedded inbondable material 802, may remain connected. Alternatively, end effector804 may be removed and another fastener of a similar or different designmay be connected to an implanted embedding fastener 800, connecting bymechanical means as described, for example, by threading. In a furtherembodiment, a fastener such as described in the incorporated relatedprior patents and applications may be fastened to an implanted orinstalled embedding fastener 800, then secured in its respective manner.For example, a pointed polymeric fastener may pierce body tissue andenter secured embedding fastener 800, connecting by, for example, pressfitting, or threading into a bore within embedding fastener 800. Theadditional fastener may be distally fastened into the bore usingvibratory energy as detailed in this specification. Once secured withinembedding fastener 800, a head portion of the polymeric fastener maythen be formed to cap and secure the tissue, using a vibratory endeffector, such as is described with respect to FIGS. 3C or 22, forexample.

An alternative method of attaching a removable embedded fastener isillustrated in FIG. 30, wherein releasable fastener 826, in thisembodiment a pointed structure, is connected to end effector 104 throughpush and turn engagement 828 comprising a pin 832 associated withfastener 826, and an L-shaped slot 830, associated with end effector104. Pin 832 travels through slot 830 until it rests at the end of slot830, whereupon fastener 826 is retained upon end effector 104. Tofurther promote retention of fastener 826, a resilient member, such asspring 834, is provided within end effector 104 to maintain tensionbetween pin 832 and slot 830. Slot 830 may further be angled to enhanceretention of pin 832. Further, it should be understood that slot 830 maybe provided within fastener 826, and pin 832 may extend from endeffector 104. This embodiment has the additional advantage of providinga current conducting metal to metal contact surface between end effector104 and fastener 826, thus preventing arcing or sparking during use.

Ported Embedded Fastener

With reference to FIGS. 35-39, a locking fastener 840 is provided withone or more channels 844, accessible when locking fastener 840 isinstalled. A channel 844 is communicative with one or more ports 842extending to a surface of fastener 840. In the example shown, a centralbore forms channel 844, and connects with two ports 842, which emergesto the surface 846 of fastener 840, for example at threads 848. Whenlocking fastener 840 is threaded into embedding fastener 800, describedabove, a heat meltable fastener 850 may be inserted within channel 844.Subsequently, vibratory energy is applied to meltable fastener 850, tosoften and at least partially melt material from meltable fastener 850,at a point distally located from end effector 804. When material of themeltable fastener 850 melts, and particularly as pressure is applied tomeltable fastener 850 in the direction of insertion, melted materialenters one or more ports 842, flowing in a direction away from channel844. When locking fastener 840 is installed in embedded fastener 800, aninterface between both fasteners is created within bore 810 and atsurface 846. Melted material of meltable fastener 850 thus flows intothis interface, and adheres therein, particularly when cooled andhardened, to further secure fasteners 800 and 840. Where the interfaceincludes shapes, such as threads 848 and mating threads 856 within bore810, cooled material of meltable fastener 850 further forms a mechanicallock 858, in addition to or as an alternative to an adhesive lock asdescribed.

A guide port 852 may be provided within meltable fastener 850, operativeto set and maintain alignment of meltable fastener 850 with post 106,the latter disposed at the distal end of end effector 804. Meltablefastener 850 may further be provided with a tapered or pointed end 854,operative to promote initial melting of meltable fastener 850 throughvibratory energy, by concentrating vibratory forces within a smallersurface area. Pointed end 854 may further serve to pierce body tissue orother materials, should that be advantageous.

With reference to FIG. 39A, in another embodiment, fastener pin 860 issized to fit through port 842 in threads 848 or surface 846 of lockingfastener 840, as previously described. Embedded fastener 800 is furtherprovided with port 862, sized to admit passage of pin 860. Whenfasteners 800 and 840 are fastened, ports 842 and 862 are aligned topermit passage of pin 860 in one or both of directions “A” or “B”, asconvenient for the practitioner. Pin 860 may be sized to be retainedwith ports 842, 862 by being press fit. Alternatively, fastener pin 860may include bondable material, heat softenable with the application ofvibratory energy, whereupon pin 860 becomes tacky and or conforms togaps or a roughened surface within ports 842 and 862, thereby lockingfasteners 800 and 840 in respective fastened alignment. Alternatively,pin 860 may be retained by threading, adhesive, or other known means forretaining a pin within an aperture. Pin 860 may further be sufficientlylong to pass entirely through locking fastener 840 and at least aportion of embedded fastener 800.

Offset Shaft Collar

FIG. 12 shows an embodiment of a fastener 200 of the present invention.Although fastener 200 is particularly well-suited for used with a spinalcage implant, it can be used for other clinical situations as well.Fastener 200 has a shaft 202, which can be threaded (not shown) or notthreaded (shown). At a distal end, shaft 202 terminates in a tip 204 andat a proximal end, shaft 202 includes a head 206 that is provided with arecess 208 (FIG. 13) into which a pin of an end effector can matinglyengage. Head 206 has a lip 210 that only partially extends around thecircumference of shaft 202. As show, lip 210 extends about half (180°)of the circumference, but any angle can be used.

FIGS. 13 and 14 show fastener 200 fixed to a spinal cage 212. As istypical for these types of implants, spinal cage 212 includes a recessedarea 214 configured and designed such that an inserter (which can alsomate with the centrally located threaded screw hole 216) can be used tofacilitate implantation. Spinal cage 212 includes a plurality offastener holes 218 that under the prior art a traditional bone screwwould be used to secure cage 212. Fastener holes 218 are located alongthe periphery of recessed area 214, creating a step. In order toaccommodate for this step, lip 210 extends about half of thecircumference. The geometry of lip 210 also facilitates the bond. Withother fastener designs, the bonding occurs with the far tip of thefastener. In contrast, fastener 200 uses a shear joint with the diameterof head 206 slightly larger than hole 218. FIG. 73 illustrates fastener212 within the spine 2000, between vertebrae 2002.

Fastener 200 and cage 212 can be made of the same material (such asPEEK) or different materials. In this regard, cage 212 can be made of adifferent thermoplastic material than that of fastener 200.Alternatively, cage 212 need not be made of a thermoplastic material.Where dissimilar materials are used, bonding occurs through aninterlocking of bondable material between fastener 200 and cage 212, orinterlocking of bondable material and the physical structure of theobject to be bonded.

Knotless Suture Fastening

Although the present invention includes fastener concepts that eliminatethe need for sutures (so-called “sutureless fastening”). The presentinvention also includes fastener concepts that use suture, but withoutthe need for knots (so-called “knotless fastening”). FIGS. 19 and 20show a knotless fastening system 300. System 300 includes an anchor 302that is similar to the anchors of the inventors' prior applications anda fastener cap or tack 304 that is also similar to the fastener cap ofthe prior applications. In this regard, anchor 302 is shown threaded,but could be otherwise provided with protrusions or other surfacefeatures for engaging the tissue into which it is inserted.Alternatively, it could be smooth.

Anchor bore 306 is configured and dimensioned to receive shaft 308 oftack 304. Bore 306 can be substantially cylindrical or can be configuredfor holding an allen-type wrench. The figures illustrate an anchor borethat is square-shaped with rounded corners, although other allen-wrenchshapes such as hexagonal shaped, star-shaped, pentagonal shaped, or thelike may likewise be suitable to allow torque to be imparted to theanchor in order to help drive the anchor into bone, tissue, or implantmaterial. An anchor channel 310 extends through anchor 302 and anchor302 is also provided with slits 311 so that a suture does not becometangled during insertion and can slide when tightening.

Various methods are disclosed in U.S. Patent publication 2007/0208378for securing sutures. With reference to FIGS. 75-77, several suchmethods are illustrated. However, anchors 3900, 3900A and 3900B arecontacted by end effector 104 and or horns adapted to fit andcommunicate vibratory energy to the anchor, as shown and described forexample with respect to fastener 826 of FIG. 30, and horns 2100 of FIGS.59 and 2310 of FIG. 61, whereupon the anchor may be caused to soften,melt or deform to lock suture 3902 within the anchor.

For example, a suture 3902 is passed through body tissue, and one ormore strands pass through a gap or aperture in an anchor 3900, 3900A,3900B comprising bondable material. An end effector of the invention isapplied to the anchor to cause melting of the bondable material,trapping the suture strands therein.

With respect to FIGS. 75 and 76, horns 3908 are caused to contact anchor3900 or 3902 and transmit vibratory energy into anchor 3900 or 3900Asufficient to cause softening or deformation thereof, and to therebybind sutures 3902. Pressure may be applied in the direction of the heavyarrows within horns 3908, during and or after application of vibratoryenergy, to improve bonding.

With reference to FIG. 77, end effector 104 is provided with a tip 3904adapted to fit within recess 3906 of anchor 3900C, and to transmitvibratory energy to anchor 3900C to cause softening and deformationthereof, sufficient to bind sutures 3902 within anchor 3900C. Pressuremay be applied in the direction of the heavy arrow within tip 3904,during and or after application of vibratory energy, to improve bonding.

If the anchor and sutures are of the same material, the anchor andsutures may become welded. Alternatively, the anchor may be providedwith a tortuous pathway for the strands, such that as vibratory energyis applied to the anchor, the anchor is deformed and the suture strandsare mechanically locked within the anchor.

Further, the end effector may be driven into the anchor with vibratoryenergy, thus displacing material of the anchor to cause compression ofthe suture strands, binding the suture strands within the anchor. Theend effector is thus advantageously shaped to penetrate and displacematerial along a predetermined path and direction. For example, fastener826 of FIG. 30 is well adapted to penetrate a monolithic anchor,particularly where there is no established entry portal.

In an additional embodiment, more than one end effector may be appliedto an anchor from opposing sides, whereupon vibratory energy andpressure caused by pinching of the anchor between the end effectorsoperates to compress the anchor and thereby bind one or more suturestrands within the anchor. The end effectors may further be shaped tohave contact the anchor along an increased surface area, improving thetransmission of vibratory energy in the anchor.

A tack channel 312 (created by the forked end of shaft 308) extendsthrough tack 304 such that one or more sutures 314 can extend throughboth anchor 302 and tack 304. When tack 304 is partially inserted inanchor 302, suture 314 can freely move since anchor channel 310 isaligned with tack channel 312. However, as tack 304 is further insertedin anchor 302, channels 310 and 312 misalign, trapping suture 314. Whenthe bonding of anchor 302 and 304 occurs, knotless fastening of suture314 is achieved. Experimental studies have shown that with anchor 302and tack 304 made of PEEK and suture 314 made of polyethylene, knotlessfastening can be achieved without any melting or degradation of thesuture material. Although a single suture lead is shown in FIG. 20,there could be two leads through one side of anchor 302 and a loop ofthe suture for holding tissue out the other.

As discussed in connection with other embodiments, tack shaft 308 mayhave a cross-sectional shape corresponding to the shape of the anchorbore 306. One potential advantage of this embodiment of the invention isthat it may allow the physician to apply a greater amount of torsionalforce to turn the anchor further into or out of the bone, tissue orimplant material either before or after the anchor and tack have beenbonded together. This would allow depth control of insertion and/orfurther control of the suture tension. Rotation of the tack can beachieved in several different ways. For example, an open-ended wrenchmay be used to grip the tack shaft and turned in a clockwise orcounter-clockwise direction. Similarly, the tack lid 316 may beconfigured to receive a wrench that allows the fastener assembly to berotated in or out of position. Tack lid 316 may include a bonding recess318 that allows a bonding device to be aligned with and impart energy tothe anchor. The bonding recess also may be configured to receive a tooleither before or after bonding, or both, that allows a physician tomanipulate the fastener. Thus, the shape of the bonding recess may beconfigured to receive an allen-type wrench, a screwdriver, or the likeso that torsional forces may be exerted on the fastener. Alternatively,the outer periphery of tack lid 316 may be shaped to engage a tool, forexample, while tack lid 316 is illustrated as round, it may be square,or hex shaped.

Providing features in the fastener that allow a physician to manipulatethe assembly may be useful in several different ways. For instance, sucha configuration may allow a physician to bond the assembly together andthen rotate it to further deploy the assembly into the body. Such aconfiguration also may facilitate easier removal of the assembly at alater time. This configuration also may permit a physician to make oneor more adjustments in the deployment or positioning of the fastenerassembly, either during the initial procedure or later in time. Whilesuch benefits each have advantages, it should be noted that noembodiment of the invention requires these advantages to be realized inorder to fall within the scope of the invention.

Bonding of the tack to an inside bore of an anchor may result in acollapse of the tack during the bond. As a result of this collapse, thegap distance between the anchor top surface and the underside surface ofthe tack may decrease. This reduction in the gap may be beneficial forfurther ensuring that the material disposed in the gap is more securelyheld in place by the fastener assembly. For instance, the bondingprocess may cause the gap to be reduced 1 mm or more due to bonding.This reduction may therefore cause the cap lid and top of the anchor toimpinge on the tissue or implant materials disposed in between thesesurfaces.

In some instances, it may be desirable to fine-tune the security of thetissue and compression against the bone. As mentioned above, thefastener may be configured to receive a tool that allows manipulation ofthe assembly. In this manner, the fastener lid 316 may be manipulated todrive the anchor 302 and tack 304 further into the bone. This woulddecrease the distance between the cap lid 316 and bone, better securinga thinner tissue or implant material disposed therebetween by placing itunder more compression. Alternatively, if it was thought that tissue wasunder too much compression the fastener cap could be turned the oppositedirection increasing the gap between the bone and fastener lid. A washermay be disposed between the lower surface of the cap lid 316 and thetissue or implant material that is being fastened in place. As the caplid is rotated or otherwise manipulated, the washer may help reducedamage to the tissue or implant material from shearing forces that maybe imparted from rotation of the cap lid 316.

Additionally, such a configuration may allow the anchor placement to beadjusted even before bonding takes place. For example, the anchor may beplaced in a first position. Implant material or tissue may be disposedbetween the anchor and a fastener. A portion of the fastener may beinserted through the implant material or tissue and into the anchorbore. If the physician then determines that the anchor position needsadjustment, the cap may be rotated to move it further into or out of thematerial in which it is placed. Once the anchor is in a desiredposition, the cap may be bonded or otherwise secured to the anchor. Asnoted above, further adjustments in position of the assembly may be madeeven after the assembly is secured together.

Bonded Flange Fastener

With reference to FIGS. 52A-B, a fastener 1700 is provided, adapted tobond an implant 1710 to body tissue 1712. Fastener 1700 includes one ormore flanges 1714 or tabs projecting from implant 1710, and being formedof a bondable material. Fastener 1700 is advantageously used where theimplant has the form of a shell, surface layer, or liner 1716, and whereliner 1716 is advantageously formed as a smooth, continuous surface,without projecting mounting posts, or holes through which a fastener maypass. FIGS. 52A-B are cross sectional illustrations through anacetabulum, an area of roughly hemispheric shaped body tissue, and animplant 1710, having a corresponding mating shape. The discussion withrespect to the acetabulum applies equally to other bearing surfaces,such as condylar surfaces, or other lined surfaces of the body.

An implant base 1714 is fastened to body tissue 1712 at a locationbeneath or adjacent to the intended implantation site for liner 1716.Implant base 1720 is attached to body tissue in accordance with anyknown manner, or in a manner disclosed herein. Implant base 1720 hasmounting projections 1718 positioned to cooperate with flanges 1714 offastener 1700. After implant base 1720 is secured, liner 1716 ispositioned in the body, and flanges 1714 are attached to mountingprojections 1718 using vibratory energy. Flanges 1714 and mountingprojections 1718 may be provided in the form of mating flanges, flangeand posts, mating posts, or any other cooperating projections which maybe heat bonded together upon the application of vibratory energy. Twoforms of mounting projection are illustrated, as 1718 and 1718A.Projection 1718 extends beyond a final position, and projection 1718Aterminates at a final position which does not interfere with properfunctioning of the body, or is potentially useful for proper bodyfunctioning.

With reference to FIG. 52B, it can be seen that projection 1718 andflange 1714 are bonded and bent to rest at a final position 1722.Bonding may occur either before or after bending. Bonding for projection1718A differs in that only flange 1714 is bent to contact flange 1718A,and flange 1714 is then heated using vibratory energy to mold onto andbond to flange 1718A.

While two variations of an implant base projection 1718, 1718A areshown, it should be understood that a single style may be advantageouslyemployed around the entire circumference of the union between implantbase 1720 and liner 1716. However, if the style of bonding is to change,a division or seam in flange 1714, or projection 1718, may be providedto facilitate a transition.

Bonding may be improved by providing a roughened or porous surface, orat least one cavity, on projection 1718, 1718A, or on flange 1714.

In another embodiment, flange 1714 is fastened directly to bone or bodytissue adjacent to the site of implantation, using vibratory energy toheat flange 1714, whereupon flange 1714 may be shaped to conform toexisting body tissue structure, and may bond thereto, for example, byadhesion or mechanical interlocking. Body tissue may be provided with aroughened or shaped surface to promote bonding with flange 1714.

To further secure the liner, adhesive may be applied to an inner surfaceof the liner before mounting and attachment.

Headless Fastener

In another embodiment of the invention, illustrated in FIG. 46G, afastener 1240 is provided, fastenable in a manner described herein, thefastener passing, for example, through an aperture or bore. However, thefastener is not provided with a head or widened portion operative toprevent the fastener from passing completely through the aperture. Fordistally secured fasteners, described herein, there is a reducedpossibility for the fastener to pass completely through the aperture, asthe distal end of the fastener is securely fixed. Where the point offastening is fixed relative to the location of the entry of the bore, afastener head can be avoided. In this manner, the fastener may have anexcess length, and be trimmed flush after being secured. Alternatively,the fastener may be provided with a length predetermined to lie flushwith a surface through which the fastener is passed. Fastener 1240 isdescribed further, below.

With reference to FIG. 49, in a further alternative, a head portionprovided as a mountable cap 1516, may be bonded to fastener 1240 usingvibratory energy, as described herein, after the fastener has beendistally secured and trimmed. Reference may be had to a furtherdiscussion of FIG. 49, below.

Spacer

With reference to FIGS. 54 and 54A-C, implant 1900 may be positioned andsecured in a precise location, in accordance with the invention, throughthe use of a progressively widening spacer. Examples include conicalspacer 1902, or wedge spacer 1904. Spacers 1902, 1904 advantageouslyinclude a surface or at least partial coating of bondable material asdescribed herein, or alternatively, fasten to one or more surfaces ofimplant 1900 that include bondable material. Any of fastener 1902 or1904, implant 1900, or implant base 1906 may be provided with aroughened or porous surface, or a surface with at least one cavity, intoor onto which bondable material may bond.

Due to the ramped shape of spacer 1902, 1904, a progressive insertion ofthe device produces a concomitant displacement of the implant to beaffixed, relative to the body tissue proximate the implantation site.Spacers 1904, 1902, and 1906 are placed at different locations, so thatthey may cooperatively displace the implant, and offer greater strengthwhen affixed. Spacer 1906 is of a different size than spacer 1902; arange of sizes is advantageous where gaps of differing size are requiredto be formed. A tool engaging structure, such as an aperture, groove, orslot 1908 may be formed in a spacer, as shown in spacers 1902 and 1906,which may be engaged by a tool to facilitate placement or removal, as bytwisting.

FIG. 54C illustrates an alternative form of spacer 1910, having a spacercore 1912 which may be driven into the interior 1914 of spacer 1910 todrive outer walls 1916 apart, either before or after spacer 1910 hasbeen implanted within the body, and then maintain outer walls at a fixedorientation. An aperture or other tool engaging structure, such as hexreceiver 1918 may be provided to enable driving core 1912 into spacer1910, as by pushing, or engaging mating threads 1920, 1922. Core 1912may alternatively be provided as a cam structure, rotatable to pushwalls 1916 apart. Core 1912 may be a separate part, or attached tospacer 1910, for example by living hinge 1924 or other flexiblestructure.

Spacers of the invention, including spacer examples 1902 or 1904, areaffixable in a predetermined location, through the use of vibratoryenergy. Once in position, proximal or distal vibratory fastening, asdescribed herein, is used to bond spacer 1902 or 1904 to implant 1900,or to body tissue 1924, adjacent implant 1900.

End Effector with Cartridge Heater

Another exemplary instrument 110 is illustrated in FIGS. 2A and 2B. Asmall cartridge heater 116 may be used to deliver thermal energy. Heater116 may be a SUNROD ⅛ inch cartridge heater, for example. To preventheat build up upon the outside shaft 112, an insulating region 114 maybe formed between heater 116 and shaft 112. In FIG. 2A, four set screws118 are used to create the insulating region 114, which in this exampleis an air barrier, while in FIG. 2B, a single set screw 118 is used.

Configurable End Effector Face

Referring to FIGS. 3A-3K, energy emitting instruments may includevarious horn or end effector configurations. It has been discovered thatfor a fixed set of parameters (energy, power, time, etc.), the bondingor bond characteristics can be varied depending on the configurations ofthe horn or end effector. For example, if extension 122 is made longeror the angle of the tip is changed, the stake or bond created can beadjusted. In FIG. 3A, the horn 120A emits energy to the top surface ofthe implant as well as the central core via an elongate extension 122A.The horn 120B of FIG. 3B is recessed to hold the thermoplastic implantduring bonding or staking. In FIG. 3C, the horn 120C is concave toprovide a rounded surface to the implant after bonding. As discussedbelow, horn 120C has been found to be particularly suitable for staking.The horn 120D of FIG. 3D is concave and includes a central extension122D to deliver energy throughout the implant. In FIG. 3E, the horn 120Eincludes a spike 124E which may be disposed within an implant. The horn120F of FIG. 3F includes a threaded pin 126F which may be received by abore in the implant. In FIG. 3G, the horn 120G includes dual spikes124G. The distal portion of the horn 120H of FIG. 3H may be dimensionedto fit within the thermoplastic implant. In FIG. 3I, a sleeve 128I isdisposed about the horn 120I and implant. A side-bond horn 120J is shownin FIG. 3J, wherein the horn or engaging portion 128J is disposed alonga side surface 130J. In FIG. 3K, a dual horn bonder 120K is used tosimultaneously bond two fasteners 130. It should be noted thatgeneration of heat through an extension such as 122A, 122D, 124E, 126F,124G and 128J will vary with respect to that generated through thebroader direct contacting surface 124D, and may be diminished.

In FIGS. 4A-4C, an instrument 140 is shown which includes threedifferent horn or end effector configurations in one design. Theinstrument 140 can be configured to produce a roughened or complexsurface (FIG. 4A), for producing an aperture (FIG. 4B), and forflattening or contouring a surface (FIG. 4C). In FIG. 4A, a center shaft142 is extended distally from the instrument 140, and outer shaft 144,which slides over center shaft 142, is also extended distally. Thisproduces an outer circle and an inner circle on a surface when vibratoryenergy is applied to end effector 104. It should be understood that avariety of patterns could be produced in this manner, by changing theshape and relative extension of shafts 142, 144, or by adding additionalshafts. In FIG. 4B the outer shaft 144 has been retracted into thebonding instrument, leaving only the center shaft 142 extended. In thisposition, the instrument 140 will form an aperture in bondable material,for example in preparation for adding cap 1010 (not shown), detailedelsewhere herein. Finally, FIG. 4C shows both the center and outershafts 142 and 144 retracted into the instrument. Sheath 146, whichsurrounds instrument 140, has also been retracted. In this position, theinstrument 140 is in a contouring horn configuration. The distal surface148 of the contouring horn may be used to reshape a thermoplasticimplant, such as the head of a fastener. A flat surface is shown,however surface 148 may be curved to produce a rounded, smooth surfaceafter application of vibratory energy.

In use, the instrument of FIGS. 4A-4C may be reconfigured quickly by theoperator as required during the procedure. In each configuration, theinstrument is configured with the appropriate shafts 142, 144 and sheath146 (if present) extended or contracted. Extended shafts 142 and or 144may thereby come in contact with bondable material to be affected.Energy, such as vibratory energy, may be emitted from the center andouter shafts to create a roughened surface on the implant, to create anindentation or blind hole in the implant, or to create a through hole inthe implant. The type of fastening desired and the intended fastener tobe used will determine how deep the bonding-surface horn should be movedinto the implant. With the staking/bonding surface formed, the outershaft 144 is retracted into the instrument (FIG. 4B).

The distal portion of a fastener may be placed in or on the bondingsurface of the implant, and the end effector may be placed on thefastener with the center shaft extending into a bore in the fastener.Using the desired parameters, the operator emits vibratory energy fromthe end effector to bond and/or mechanically interlock the fastener tothe implant. Once bonded or staked, the fastener may be contoured orreshaped or resized with the contouring-horn of the instrument byretracting the center shaft and optionally retracting the sheath aroundthe instrument (FIG. 4C).

Movement of shafts 142, 144 and or sheath 146 may be accomplished byknown methods of mechanical action, for example guide shafts extendingthrough end effector 104, or electromechanical or pneumatic actuatorswithin the distal portion of end effector 104.

Hollow tubular outer shaft 144 may additionally be used for removingbonded implants. When used without center shaft 142, it may be used tosurround an implant bonded to body tissue or another implant with a heatmeltable bond, as described herein. In this application, vibratoryenergy is transmitted through hollow shaft 144 and the shaft is placedin contact with the melted bond. As bondable material is softened, shaft144 is advanced, until a sufficient amount of the bond is severed byshaft 144. Combined with mechanical action applied to the handpiece, asneeded, a bonded part now housed within shaft 144 may be thus loosenedand removed.

Shaft 144 may be used when extended alone in the configuration shown inFIG. 4A, or may be provided in a fixed or dedicated end effector or endeffector endpiece containing only shaft 144. Further, it should beunderstood that shaft 144 may be provided in configurations adapted tothe shape and depth of the bond of specific parts to be removed.

Additionally, shaft 144 or 142 may be used to core or drill,respectively, in bondable material. In this manner, apertures may beformed for inserting or attaching additional implants, which mayoptionally be secured in place with vibratory energy, as describedherein.

Coated Fastening Base

With reference to FIG. 48, a coated implant 1500, shown bisected along alongitudinal axis, includes a core 1502 and a coating 1504 of bondablematerial. In the embodiment shown, core 1502 is metallic, and coating1504 is bone cement. However, the coating may be any bondable materialas described herein, and core 1502 may be the same material as thecoating, or any other material of suitable strength to which the coatingmay be securely attached, as by adhesion or mechanical attachment. Theform of coated implant 1500 shown is that of a rod, sized and shaped toenter an intramedullary canal; however, a different shape may beselected to advantageously serve as a base for fastening at least oneother fastener, depending upon the application and location. The coatingis applied over at least a portion of the exterior surface of the core.

Coated implant 1500 is placed in the body as a point of attachment forother implants, for example any of the fasteners of the invention. Thecoated implant is advantageously shaped to provide a surface forattachment of numerous fasteners, or one or more fasteners at a varietyof possible locations. Fasteners may be bonded to the coated implantusing proximal or distal vibratory fastening, as described herein, or acombination of vibratory and mechanical fastening.

Core 1502 may be attached within the body using any means known in theart. In the embodiment shown, the distal end 1506 of core 1502 isprovided with threads 1508, which may connect to mating threads of animplant previously implanted and affixed within the body, for exampleembedded fastener 800. In this manner, core 1502 functions as describedfor end effector 804.

Once secured, coated implant 1500 forms a base for fastening otherfasteners, for example the fasteners illustrated in FIGS. 46D-H. Withreference to FIG. 49, an elongate fastener 1240 may be seen attached tocoated implant 1500 at a distal end. Coated implant 1500, in the exampleshown, may be attached as described with respect to fastener 900, ofFIG. 43. Other means of attachment to secure coated implant 1500, asdetailed herein, may alternatively be used. For example, fastener 1240is distally bonded to coating 1504, and has been trimmed at a proximalend at the surface of bone 882. As such, fastener 1240 stabilizes coatedimplant 1500 by restricting motion of coated implant 1500 withinintramedullary canal 1222, and particularly in a longitudinal direction.

Fastener 1240 is shown without a cap 1010, however fastener 1240A isadditionally, shown, provided with a mountable cap 1516, shown bothseparated and attached. An optional aperture 1512 may be provided infastener 1240, operative to receive a post 1514 projecting frommountable cap 1516. Post 1514 aligns cap 1516, and provides greatersurface area for bonding of cap 1516 and fastener 1240 upon theapplication of vibratory energy, as described herein. It should beunderstood that post 1514 and aperture 1512 may be eliminated, andvibratory fastening may still be accomplished. Mountable cap 1516prevents fastener 1240A from moving inwardly with respect to the centerof the bone, and falling out of the opening in cortical bone throughwhich it resides.

With further reference to FIG. 49, one or more fasteners 1518, 1520, ofthe invention are distally fastened to coated implant 1500. In thismanner, the distal ends of fasteners 1518, 1520 which are embedded incoating 1504 are fixed in position relative to each other. However, theproximal ends, projecting through the outer cortical bone of bone 882,are movable with respect to each other due to a fracture 918 in bone882. To stabilize fasteners 1518, 1520, and to secure fracture 918 in aclosed configuration, plate 1522 is provided, passing over fasteners1518, 1520, before caps 1010, 1516 are formed and attached,respectively. In this manner, both proximal and distal ends of fasteners1518, 1520 are fixed, and thus fracture 918 is stabilized, and properhealing is facilitated.

Expanding Fastener

With reference to FIGS. 88-90, an expanding fastener 3300 is provided,adapted to pass through an opening 3304 in a wall 3302 into a hollowspace 3306, and expand within hollow space 3306 thereby resistingwithdrawal through opening 3304. Fastener 3300 is fastened usingvibratory fastening in accordance with the invention.

In particular, fastener 3300 is provided with one or more wings 3308,which are attached to a flange 3312. Wings 3308 are passed throughopening 3304, the latter sized smaller than flange 3312. In this manner,fastener 3300 is prevented from passing completely through opening 3304.Wings 3308 are adapted to fold at living hinge 3310, or alternatively,wing 3308 may resiliently bend, whereby wings 3308 expand away fromopening 3304 when folded or bent, thereby creating a profile that is toolarge to pass through opening 3304. In the embodiment shown, a post3314, connected to wings 3308 at a distal end 3316 thereof, passesthrough opening 3304, together with wings 3308. After wings 3308 andpost 3314 are passed through opening 3304, post 3314 may be pulled in adirection away from hollow space 3306, thereby causing wings 3308 toexpand as described, as illustrated in FIG. 89.

Fastener 3300 may be fabricated entirely from a bondable material, forexample a polymer; however, in the embodiment shown, at least flange3312 and post 3314 are coated with, or made entirely from a bondablematerial. In FIG. 90, post 3314 and flange 3312 have had vibratoryenergy applied at an area 3318, whereby material of post 3314 becomesbonded to material of flange 3312, thereby securing wings 3308 in anexpanded position. Post 3314 may be cut to a desired length afterfastening.

Flange 3314 may be adapted to enable attachment of body tissue or otherimplants, by being provided with one or more apertures 3320, operativeto retain a suture 3322, or other material to be secured. Alternatively,flange 3314 may be provided with a threaded bore 3324, or otherstructure useful for attachment as known in the art. Alternatively, post3314 may be provided with one or more apertures 3326, or may be providedwith a central bore 3328, which may be threaded, or may be self tappedby a screw driven therein.

Fastener 3300 enables fastening through an aperture or opening 3304where the medical practitioner does not have access to hollow space 3306beyond opening 3304. It should be understood that hollow space 3306 maybe cancellous bone or other tissue which is sufficiently soft to bedisplaced when wings 3308 are bent. Vibratory energy enables a fastener3300 of simple and reliable construction, as there is no need for athreaded post and a threaded aperture at distal end 3316, as is requiredin prior art fasteners.

Parameters and Additives

Monitoring and controlling the parameters ensures proper bonding ofthermoplastics. FIG. 5 illustrates the various parameters that may bemonitored and controlled for the system of the present invention. Theparameters include, but are not limited to, the type of energy to emit,type of thermoplastic material, the size and configuration of theimplant, the thickness of the implant, implant surface geometry, theaqueous environment, energy time, energy power, and frequency of theenergy, amount of pressure applied to the implant during and afterapplication of the energy, the geometry of the horn, the boost orattenuation of the end effector, the density of the implant, the amountof collapse of the thermoplastic material, the depth into tissue theimplant is to be inserted, and the type and amount of any therapeuticagent that may be delivered.

There are several factors that effect bonding or staking ofthermoplastic materials. One is hydroscopicity, the tendency of amaterial to absorb moisture. If too much fluid gets between the parts itcan decrease the bond or create a foam which prevents proper bonding ofthe materials. Therefore, the bonding of thermoplastics may be performedunder vacuum/suction, or a hermetic seal may be placed around thethermoplastic during the bonding process. Also, the bonding may beperformed using a cannula which prevents fluid from entering the bondingarea. Furthermore, pressure, such as air pressure or compression force,may be applied during bonding to prevent entry of moisture or liquid.

Additives

In addition to or in place of reducing moisture from the bonding area,certain agents can be used to aid in the bonding process. Such agentsmay include filler material, glass filler, glass fiber, talc, andcarbon. The agents may be placed at the bond site as a temporary bondingenhancement means or may be a permanent agent to enhance the bonding.For example, the agent may be placed within the bonding region of PHA,PEEK or PLLA. The agent may be left in place to bond or could beremoved. It is contemplated that any amount of agent may be used toenhance the bond strength of the thermoplastics. In an exemplaryembodiment, the amount of agent may be about 10 to 20 percent.

Moisture may further be eliminated or prevented from entering thethermoplastic material through the use of desiccants. Desiccants may beadded prior to or during the staking or bonding process. Also, thethermoplastic material may be stored using desiccant material to preventchange in thermal properties. It is contemplated that this moisturereducing means may be applied to any polymeric material.

Another factor which may affect bonding or staking of thermoplasticmaterial is pigments, particularly white or black coloring. In manymaterials used in medical applications, white pigment is added to thepolymer to make it appear sterile. Some pigments may negatively affectthe bonding and staking characteristics of the material. Accordingly,pigment-free thermoplastics, such as PEEK, are advantageously used forfastening.

Mold release agents also affect the thermal properties ofthermoplastics. Polymeric components are usually formed in a mold tocreate a desired configuration. The component is easily removed from themold because a release agent is placed between the mold and polymer.These agents, lubricants, plasticizers, and flame retardants cannegatively affect the bonding ability of the polymer. Thus, it ispreferred in the present invention that PHA, PEEK, PLLA, and otherthermoplastics used for bonding or staking are substantially free ofthese substances.

In addition to avoiding release agents, pigments, and moisture, thestaking and/or bonding of thermoplastic materials may be furtherenhanced by adding minute metallic material to the polymer. The metallicmaterial may be metal flakes or metal dust. Examples of such metalinclude iron particles, chromium, cobalt, or other suitable metals. Themetal may be embedded within the polymeric material to enhance thethermal properties. Alternatively, or in addition, the metal may beapplied to the surfaces of the polymeric material. Energy applied to thepolymer would heat both the polymeric and metallic material providing afaster and more uniform thermal profile. It is contemplated that glassfillers, carbon fillers, talc, or combination thereof may also be usedin addition with or in lieu of the metallic material, although somematerials, while conferring desired properties, may adversely affectbonding, at least depending on the concentration used.

Energy Type

Other factors affecting the thermal characteristics of thermoplasticsinclude size, thickness, surface geometry, material properties of thethermoplastic, and the type of host tissue involved in the bonding orstaking, i.e. soft, hard, dry, wet, or moist tissue. These and otherfactors are explained in more detail with reference to FIG. 5.

Furthermore, how the thermoplastic is staked or bonded is an importantcharacteristic of obtaining a robust mechanical interlock or thermalbond. The type of energy used is one way to control the process. Aspreviously mentioned, various energy sources may be used to bond and/orstake polymers. In an exemplary embodiment and as used primarilythroughout the invention, ultrasound energy is used to create vibrationswithin the polymeric material thereby exciting and heating the moleculesto transition to a tacky state. Two or more different types of energymay also be used. For example, ultrasound may be used to bond apolymeric component to another component, while resistive heating may beused to contour the surface or change the geometry of the materials. Thesurface of the component may be smoothed out or sculpted using resistiveheating.

The intensity and duration of the energy source impacts the quality ofthe bond or mechanical interlock. For instance, the amount of energyused affects the thermal properties. Therefore, the energy may becontrolled by the operator depending on the component to be bonded orstaked. A switch, dial, or other control may be placed in connectionwith the energy source to vary the intensity of the energy applied. Forexample, the amount of current supplied to the instrument may be variedor controlled. In an exemplary embodiment, the ultrasound power may bevaried, for example, between 80 and 100 Watts. The amount of time theenergy is applied affects the bond or staking as well. The time may bevaried from milliseconds to hundredths of seconds to actual secondsdepending on the desired end result. Thus, controlling the time ofexposure to the energy source can be used to limit the amount and thedegree of thermoplastic material which softens and becomes tacky. In anexemplary embodiment, energy may be applied from 0.1 seconds to 3seconds, such as approximately 0.3 seconds. In case of RF and ultrasonicenergy, the frequency of the energy may be varied to affect thesoftening or melting of the thermoplastic. It is also contemplated thatthe amount of time that energy is applied may be controlled not only bythe operator but also via radiofrequency, optical, radiowave, etc. Acomputer or other microprocessor may send signals to the energy emitterto turn the energy on and off.

Pulsing of the energy source may likewise be used to intermittentlyapply energy to the site or to vary characteristics of the energy sourceover time, such as the power, frequency, or pressure, to enhance bondingor mechanical interlock and avoid tissue necrosis. That is, the energymay be emitted, then relaxed, then emitted, etc.

Pressure

Controlling the pressure applied to the thermoplastic material also maybe used to affect the process. During bonding or staking, a handpiece,an anvil, a horn, end effector, or combinations thereof may be used toapply controlled force against the component. After completion, whilethe material is cooling, the force may continue to be applied to ensureproper bonding and/or mechanical interlock of the materials. Thehandpiece, anvil, horn, and end effector may be made of aluminum,titanium, or other suitable material. Also, the pressure may be varied,increased or decreased, during the process. In an exemplary embodiment,the pressure may be applied by the operator or may be applied with aspring. A sensor, spring, and/or piezoelectric device may be used tomonitor and control the amount of pressure applied. In another exemplaryembodiment, the bonding horn may apply ultrasound energy and pressure toa polymeric implant being attached to bone. The bone may act as theanvil eliminating the need for an anvil instrument. Also, a hard implantor another polymeric material may function as the anvil.

Furthermore, the placement of the energy source on the thermoplasticaffects the bond or staking. The energy may be applied to one side ofthe polymer, through the center of the polymer, to two or more sides ofthe polymer, or to generally the outer surface of the polymer.

Collapse

Controlling collapse is another factor in achieving an effectivethermoplastic bond or staking. For instance, the time and materialcollapse may be monitored to ensure a proper effect. A measurement ofthe change of the material being bonded or staked may be made todetermine when complete. This may be accomplished by usingmicro-switches to provide precise, binary control of the mold. Also, byusing a linear variable displacement transducer (LVDT), the controlsystem can monitor the bond more precisely. Because a LVDT translatesposition to voltage, the bond and/or staking profile can be dynamicallycontrolled. For example, the initial energy delivered can be a higherwattage, then when the material starts to collapse the amplitude of thewave can be decreased.

By being able to monitor the position of the collapse, different bond orstaking profiles can be programmed into the system. In addition, tocontrol how far the material collapses, a combination of current andtime preset in the generator control system could be used. This can alsobe coupled with a defined force applied during the bond or staking.Furthermore, collapse may be controlled or monitored through the use ofa mechanical stop on the fastening device itself or on theinstrumentation. The mechanical stop would prevent collapse after apredetermined point. It is also contemplated that the collapse could bemonitored by other methods such as optics, laser, or even a hall-effectsensor.

All of the above-mentioned parameters may be monitored and controlled bya computer. The discussion relating to FIGS. 5-8, among others,illustrate instruments that may be used for controlling the parameters.Feedback may be provided by the computer to vary, start, and stop thevarious parameters. The feedback and control of the computer may beprogrammed based on the type of polymer being bonded and/or staked andthe type of material the polymer is being bonded or interlocked to. Forexample, for PEEK to PEEK bonds, the computer may apply a set ofparameters (time, power, pressure, frequency, etc.) to achieve andesired or effective bond. Other parameters may be established or presetfor other polymers, other bond materials, or for staking dissimilarmaterials.

Without being bound by any particular theory, it is generally thoughtthat the surgical system (either bonding or staking) of the presentinvention causes primarily radial deformation of the fastener. This wasdiscussed above in the context of collapse. Because the primarydeformation is collapse so that radial expansion occurs, there islittle, if any, elongation in the longitudinal direction. Detailedanalysis has shown that for a fastener or tack made of PEEK and havingtypical dimensions (head 0.180 inch; and tip 0.109 inch), there is abond collapse of 0.050 inch for set bond parameters (111 Watts; 500millisecond bond time; and 5-8 lbs force applied). As previouslydiscussed, this collapse can be increased or decreased by changing thebond parameters, the geometry of the end effector and tack, and/ormaterial of the fastener.

Instrumentation and Controls

Any known energy emitting instrument may be used with the surgicalsystem of the present invention. The instrument may produce energy suchas resistive heating, radiofrequency, ultrasound (vibratory), microwave,laser, electromagnetic, electro shockwave therapy, plasma energy (hot orcold), and other suitable energy. FIG. 1 illustrates an exemplaryhandpiece or instrument 100 that may be used with the present invention.The instrument 100 may be a vibratory handpiece with a sheath 102 tocover and protect the end effector 104 and hold a fastener. As will bediscussed in greater detail below, the instrument may be used to bond ormechanical interlock a cap of an implanted device to an anchor, orlikewise may be used to bond or mechanically interlock other componentstogether.

The sheath 102 may have a small counter bore at its tip to cover aportion of the cap. There also may be a bushing at a nodal point of thevibratory signal to prevent the end effector 104 from contacting thesheath 102. The tip of the end effector 104 has a small post 106sticking out of the bonding face which presses into a bore in the cap ofthe fastener. This can help align the fastener post into the anchor boreand keep the cap tight against the end effector face. The end effector104 may be removable to allow it to be replaced or cleaned after use.

The post 106 on the end effector 104 may be threaded or have a Morsetaper to mate with the cap. Alternatively, the end effector 104 has abore that the top of the cap mates into. The mating of the componentscould also be by threads or a Morse taper along with a straight post.Furthermore, the post could be roughened on the outside surface forbetter adhesion.

Microprocessor Control

In accordance with the invention, A DSP simplifies additional modes forfastening control. Whether an analysis is performed by a DSP, otherprocessor type, mechanical means, or by the practitioner, processingmodes for fastening in accordance with the invention include the modesdescribed as follows.

The phase angle differential between voltage and current is monitoredduring use, and changes are made to the signal to maintain a resonantfrequency. For example, the drive frequency could be varied to maintaina particular phase angle differential. An optimal or target phase anglemay be determined by a frequency tuning sweep, calculation, empiricalmeans, or a combination of these methods. This is discussed further withrespect to FIG. 67, below.

The output voltage may be varied while while monitoring powerconsumption during bonding. A device using this method must adapt to thetypically large variations in loading during the bonding step.

The stroke of the handpiece is measured by a sensor disposed within thehandpiece or end effector. This method provides the advantage of arobust and accurate measurement of the physical displacement of the endeffector.

The drive voltage is varied while monitoring the current and voltageduring bonding. The minimum impedance is then calculated in real time,to adapt to variations in the environment, particularly a medicalenvironment, during bonding.

The total power/energy applied to the bond may be calculated duringbonding, and when a total predetermined amount of energy has beendelivered the bonding step is terminated.

The total time during which power is applied during bonding is trackedand when power has been applied for a predetermined amount of time,bonding is complete and is stopped.

The Eddy or Foucault currents created by movement of the end effectorare tracked, the movements being indicative of melting activity. As theend effector vibrates, a magnetic field is changed, creating measurablecurrent which may be analyzed during bonding.

Collapse of the fastener is measured by a sensor within the end effectoror handpiece, indicative of an amount of melting corresponding to presetlevels established for correct bonding of a particular configuration.

The control methods of the invention may be combined. The methods enableadjustment of the signal for variations in the environment and loadingduring a surgical procedure.

The control modes described above may be combined with input or measuredparameters automatically by processor control, or at the election of thesurgical practitioner. In this manner a matrix for overall control iscreated by the selected parameters, and the selected control modality.Reference may be had to the following example parameters:

Implant Type 1 1 2 3 Environment Dry/Moist Wet All All Control MethodPhase Angle Min Impedance Min Impedance Stroke Term Power Energy EnergyCollapse

In each of the four examples above, selection of an implant triggersloading of the optimal phase angle, impedance, and or energy values.Environment values may be input by the practitioner, or measured by thesystem. The system may determine the type of implant based on eitherinput from the practitioner, or by sensors or switches associated withthe handpiece, whereby. For example, the particular type end effectorcurrently connected triggers a signal to the processor regarding theappropriate type and size of fastener that will be used. Alternatively,the fastener itself indicates its presence, either by physicallytriggering a switch, or by other known means of signaling, for examplean embedded RFID tag.

User Interface

FIG. 6 shows a manual control box 150. A surgeon determines the optimumor desired parameters and may then enter them into the control box 150prior to or during bonding or staking. In FIG. 7, an automatic controlbox 152 may be provided with pre-set parameters. For example, preset 1may be for implant A which has a known material, size, etc. to be bondedin a dry environment. Preset 2 may be for implant A in a moistenvironment. Preset 3 may be for implant A in a wet environment. Preset4 may be for implant B using energy source X. Preset 5 may be forimplant C using energy source Y. Preset 6 may be implant D using energysource Z. It is contemplated that any combination of bond parameters maybe pre-set into the control box.

The control box 154 of FIG. 8A is automatic. A sensor on the endeffecter 156 determines the parameters when the horn is placed adjacentthe thermoplastic material. The sensor 156 picks up material type,humidity of the environment, and any other parameter, then sends thedata to the control box. The control box 154 automatically selects thetime, wattage, and any other parameters. FIG. 8B illustrates a vibratoryenergy control box which may be used with the surgical systems of thepresent invention. Control box 154 includes a handpiece connector 154A,and interface controls 154B for changing bonding parameters.

The exemplary energy control units described herein may be used toselect and vary any of the parameters. In FIG. 8C for example, the poweror wattage of the horn is varied over time. During a first period ofbonding, a large amount of energy is delivered to overcome heat sink. Inthe second period, the energy is reduced. In a subsequent period, theenergy is maintained at an appropriate level to thermal bond or stake animplant.

Other variations of the use of a control box may likewise be used. Forinstance, a computer may be used to query or receive data about thesurgical procedure. The physician may enter an implant manufacturer, forinstance, and then select or enter an implant model, size, etc. Based onthe entered information, the computer may assist the physician byinstructing which energy source(s), horns, or other parameters may berecommended for the procedure. While the control box or computer mayautomatically select and apply a thermal profile based on expected inputparameters, the control box or computer may also allow a physician toalter or override the expected input or otherwise select a differentthermal profile. The ability to allow varying degrees of manual controlof the instrument may also be provided.

The exemplary energy control units previously described may be used toselect and vary any of the parameters. For example, the power or wattageof the horn may be varied over time. During a first period of bonding, alarge amount of energy may be delivered to overcome heat sink. In thesecond period, the energy may be reduced. In a subsequent period, theenergy may be maintained at an appropriate level to thermal bond animplant.

With reference to FIG. 63, the surgeon may manually control theparameters, or the parameters may be controlled using automation,including using a microprocessor or computer. In accordance with theinvention, a generator control unit 2500 is provided having connectionsfor grounding and a signal 2502, 2504, 2506. The generatoradvantageously includes a user interface comprising gauges orindicators, and in one embodiment an LCD or similar output screen 2510.A user keypad 2516 is provided to move a cursor or indicator on theoutput screen, whereby parameters can be selected and entered. Afootswitch, not shown, may be provided to enable the surgicalpractitioner to more easily activate the generator.

With further reference to FIG. 63, in accordance with a furtherembodiment of the invention, the surgical practitioner entersinformation pertaining to the surgical procedure through interactionwith the user interface, which includes a cursor keypad 2516 and outputscreen 2510 on the generator 2500. It should be understood that analternative and potentially more sophisticated and complete interfacemay be obtained by connecting a computer (not shown) to the generator,via a known method including USB, Bluetooth or network connection.Moreover, the generator interface may be programmed for the varioustypes of surgeries and surgical operating parameters expected to beencountered, and the generator may thereafter be disconnected from thecomputer during the procedure.

Once programmed, output screen 2510 contains menus offering the surgicalpractitioner options relevant to the procedure to be performed,including the type of procedure, and any or all of the parametersdescribed in this specification. An example of a menu is found in FIG.72. In this example, a first screen 4200 indicates an initializationphase, after which the system performs self-tests 4202, which ifunsuccessful, error codes are indicated at 4204. If self tests 4202 arepassed, the practitioner is prompted at 4206 to select the type offastener to be bonded. The practitioner makes a selection, as bypressing a button 2516 on the generator, pressing buttons 3124 (FIGS.86-87) on the handpiece, pressing a footswitch, clicking a mouse,through voice activation, or other human interface method, and thesystem advances through additional parameters, in this example promptingfor the material of the fastener in “PEEK PLLA” at 4208, fastener sizeat 4210, environmental conditions at 4212, and finally indicating a“ready” status at 4214, whereupon when ready the practitioner may startbonding.

In this manner, the practitioner has the ability to input the correctprocedure and real-time parameters, in order to enable precise controlin the use of the generator. Further, the generator can perform asophisticated analysis in order to determine the correct operatingparameters, including for example frequency, wattage, and pulsing, andthe generator may further independently vary one or more parameters overtime. Accordingly, the practitioner need not make the complexcalculations necessary in order to achieve a secure and reliablefastening, and thus time is saved, and the potential for error isreduced.

Frequency Sweep Tuning

An exemplary process for vibratory staking is illustrated in FIG. 31.The staking process begins at “start stake” 2700 by either pushing thegenerator footswitch or using the control on the hand piece. Uponstarting, the generator may first perform a “system check” 2702. Thesoftware may also check for proper grounding, ground offset issues, aswell as other vital circuits. If there are errors with the system or thegrounding, the generator can give a visual or audible indication that anerror has occurred, at “error: shutdown system” 2708, and the vibratorysignal generator may be disabled to prevent inadvertent use.

If no errors are detected, the system may then sweep a frequency range,such as from about 38.5 kHz to about 43.5 kHz, to tune the system, andparticularly to “tune stake to system resonate frequency” 2704. Currentmeasurements may be used to find the resonate frequency of the system,which in some embodiments may be close to 41 kHz. Next at “start bond”2706 the vibratory or ultrasonic signal is then sent to the hand piecewhere a resonator turns the waveform into linear movement. A maximumbonding time is determined by the user, or by microprocessor control ofthe system. If an excess time is reached, a “timeout” 2710 is signaledand the system shuts down at error 2708. When bonding is complete at“staking complete” 2712, as determined by the user or by microprocessorcontrol of the system, the generator is shut down at “stop ultrasonicgenerator” 2714, whereupon “staking complete” 2716 indicates bonding hasbeen accomplished.

Impedance Feedback

To help ensure a properly executed bond or staking, the instrument ofthe present invention may provide a positive feedback system. One way toprovide user feedback is by measuring and controlling the impedance ofthe vibratory generator. This feedback system is based on the fact thatthe load placed on the end effector affects the impedance of the system.That is, the pressure put on the end effector by the object to be bondedor staked changes the impedance within the handpiece, and specificallythe piezo stack and electronics controlling the end effector. Todetermine the handpiece impedance, the drive voltage and current throughhandpiece may be monitored during the thermal process. By using Ohm'sLaw V=IR, the impedance, Z, may be calculated from the voltage, V, andcurrent, I.

FIG. 9 illustrates one method of ensuring a consistent or desired bondor stake. The medical practitioner initiates a process in accordancewith the invention by first transmitting a low power vibratory signalthrough the end effector, whereupon the impedance of the handpiece ismeasured with no pressure applied to the end effector. This establishesa baseline impedance. Then, the end effector may be subjected to knownpressures, and the voltage and current may be measured to calculate theimpedance for each pressure. Thus a set of values is known, and may bestored within a device in accordance with the invention, to be used in asubsequent bonding process, as follows.

When a surgeon or other operator applies pressure from the end effectorto a thermoplastic implant to be bonded or staked, the actual amount ofpressure can be fed back to the operator because the pressure can becorrelated to a known impedance. Thus, “Start” 2600 corresponds tocontacting the fastener in preparation for fastening, and “Send Signal”2602 corresponds to indicating to the system that bonding should begin.

The surgeon may increase or decrease the pressure on the end effectoruntil the desired pressure is achieved. In one embodiment, theinstrument may provide audible and/or visual signals at “In Range” 2604that tests when a surgeon is applying too much or too little pressure,whereupon a signal may be indicated at “Error! Correct” 2608, or anadequate amount of pressure is applied at “Perform Weld” 2606, whereuponthe surgeon may activate the handpiece, whereupon vibratory energy isemitted in accordance with the calculated thermal profile establishedabove. When fastening is completed, the practitioner or the system stopsapplication of power at “Stop” 2610.

In another exemplary embodiment for providing positive feedback, thepressure and impedance of the handpiece, and more particularly the piezostack and associated electronic circuit, may be monitored throughout thethermal profile. In the previously described method, the proper pressurebased on impedance was achieved by the surgeon using a low power signal,and then the vibratory energy was emitted for bonding when an amount ofpressure within a range was applied to the fastener. In this method, thepressure and impedance is measured during the bond. When pressure on theend effector is applied and the bond is started, for example by a handcontrol or footswitch, the current may be measured and the impedancecalculated by a microprocessor. When the impedance is too high or toolow or outside an acceptable range indicating an incorrect appliedpressure, the microprocessor may send an audible or visual signal to thesurgeon, or may alter the signal to maintain correct bonding parameters.

Alternatively, or in addition to the signal, the microprocessor can stopenergy emission until the correct pressure and impedance is achieved,then the bonding may be resumed either automatically by themicroprocessor or manually by the surgeon. If inadequate pressure isbeing exerted, the bonding instrument may operate in a pulse mode tomaintain material in a near-bond state. This may allow the bonding tomore rapidly continue when adequate pressure is once again beingapplied.

Referring FIG. 10, circuit 2620 may be used to monitor power used by thehandpiece. Because the drive signal for vibratory energy is sinusoidal,“V(monitor)” and “V(current)” are sampled at a rate that isadvantageously at least twice the frequency of the vibratory waveform tobe produced at the end effector. Reference may be had to FIG. 70, forexample, where nodes, representatively illustrated by reference 2640,represent sample points. For example, if the waveform is a 41 kHzsinusoid, then samples are taken at least at 82 kHz. Further, if theresistances in circuit 2620 are known, and “V(current)” and “V(monitor)”are known, the impedance of the handpiece 100 may be calculated in amanner known in the art.

Also, by monitoring handpiece impedance, changes to the environment,such as moisture, ambient temperature, aqueous conditions, etc., may beautomatically compensated for by adjusting the drive waveform of thevibratory energy. For example, if for a certain material it isdetermined that 80 W of power is required for a 400 ms period to achievea consistent bond or staking, then the waveform can be adjusted toensure that this amount of energy is constantly delivered. Power iscalculated using P=IV(cos φ), where P is the average power, measured inwatts, I is the RMS value of the sinusoidal alternating current (AC), Vis the RMS value of the sinusoidal alternating voltage, and φ is thephase angle between the voltage and the current. Because the signal fromthe waveform is sinusoidal, the root mean square (RMS) voltage asV=(1/√2)A must be used.

As the impedance, Z, of the handpiece changes, the total power deliveredalso changes. By increasing or decreasing the drive voltage tocompensate for the change in the impedance, a constant power can bedelivered.

With reference to FIG. 71, in an another embodiment of the invention,impedance during bonding is monitored over time. While bonding is takingplace, during “Time (bond)”, a sudden drop off in impedance, illustratedat reference 2642, can indicate that the end effector has slipped offthe bond site, or some other error has occurred. This error can becommunicated to the medical practitioner, and or a controllingmicroprocessor, so that corrective measures may be taken.

In accordance with the invention, a phase angle differential is observedtogether with, or in place of, an impedance change as described herein.With reference to FIG. 67, an alternating current circuit under load isillustrated, demonstrating that the current and voltage oscillatesinusoidally. Unless the circuit is purely resistive or in resonance,the voltage and the current will be out of phase. This phase angledifferential “Φ” (phi) is monitored, where current “I(t)” trails voltage“V(t)” over time, and changes are made to the signal based upon theobserved phase angle differential, as well as other parameters,including the frequency, in order to maintain a resonant frequency at anarea on the end effector where it is desired for bonding to take place.

More particularly, prior to bonding, the end effector is subjected to asweep through a frequency range expected to contain an optimal resonancefrequency, beginning at a frequency lower than is expected to produceresonance, and either the phase angle differential or highest and lowestimpedance is observed. The optimal frequency and other parameterscorresponding to the optimal frequency are recorded, for example by anelectronic circuit or microprocessor, and when bonding is to be carriedout, these parameters are used as initial values.

This is further illustrated with reference to FIG. 68, wherein aparticular range of frequencies generates a disproportionate change inphase angle. The change in phase angle corresponds to resonance of theend effector or horn, and thus resonance may be inferred from the phaseangle differential. While resonance may be calculated under certainconditions, empirical data may additionally or alternatively be capturedand used to reduce the time required for determining an optimalfrequency range; the phase angle differential is one parameter that maybe monitored to determine when an optimal frequency has been achieved.

A frequency likely to be close to an optimal frequency during bonding isthus determined prior to bonding, with the end effector not in contactwith any other object. During bonding, an optimal frequency may change.In accordance with the invention, changes are made to one or moreparameters as needed, for example the frequency, to maintain resonanceof the end effector. Monitoring a phase angle differential is one of theways in accordance with the invention of maintaining an optimalfrequency during bonding. Moreover, because an optimal frequency may bemaintained during bonding, the step of first determining a likelyoptimal frequency prior to attempting a bond may be eliminated, which isadvantageous when multiple bonds are to be performed.

The foregoing methods may be used for bonding at an anti-resonantfrequency as well as at a resonant frequency. An anti-resonant, ornon-resonant frequency, can still be used to accomplish bonding,although it will generally result in higher impedance and a highervoltage requirement. Anti-resonant bonding is thus less efficient;however, it may result in a handpiece that is less sensitive to pressurechanges, and thus determining a non-resonant frequency may be useful atleast when this type of bonding is desired.

Controlled Pressure Handpiece

In accordance with the invention, a tool for producing vibratory energyis provided with a gauge positioned to respond to a differential betweena pressure created by applying a force to the handle, and the physicalresistance presented at the end effector. When excessive force isapplied, a response is generated, operative to warn the operator and orreduce power of the vibratory signal. When insufficient force isapplied, the operator is likewise warned, and or power is not yetapplied to produce vibration.

In one embodiment of the invention, a series of electrical contacts areinterposed between the handle grip and the end effector. Springs respondto relative movement of the handle and the end effector, to position thecontacts with respect to each other, in order to open or closeelectrical circuits. These circuits may be connected directly to a powergenerator, or may pass to mechanical or electronic circuits whichinitiate a warning or a change in power level.

With reference to FIG. 60, a handpiece 2200 is provided for transmittingvibratory energy, advantageously including ultrasonic energy, inaccordance with the invention. Handpiece 2200 includes a grip sleeve2202 sized to be conveniently held by a surgical practitioner's hand, orengageable with a haptic or robotic arm. A core body 2204 is sized toslide in engagement with sleeve 2202. While core body 2204 isillustrated to slide within sleeve 2202, it should be understood thatsleeve 2202 may be disposed to slide within body 2204 without departingfrom the spirit and scope of the invention. Extending from core body2204 is an end effector 104, not shown in its entirety, as describedherein. Core body 2204 contains means to produce vibratory energy, asdescribed herein, for example including a piezoelectric stack, notshown.

Extending between sleeve 2202 and body 2204 is resilient member 2206,which may have the form of a spring or other collapsible or bendableresilient element, or magnetic resitive element. End effector 104 may bepressed against a fastener of the type described herein throughapplication of force to sleeve 2202 in the direction of Arrow “A”. Theapplication of force thus causes resilient member 2206 to compress, andsleeve 2202 to overlap core body 2204. As the application of force tosleeve 2202 is reduced, resilient member 2206 acts to restore anoriginal relative position of sleeve 2202 and core body 2204. Resilientmember 2206 may be retained within a space formed between sleeve 2202and core body 2204, and may be attached to one or both of sleeve 2202and core body 2204. Other means may be provided to prevent overextending or separation of sleeve 2202 and core body 2204, as is knownin the art.

Associated with core body 2204 and sleeve 2202 are electrical contacts2210, 2212, respectively. Disposed between contacts 2210, 2212 iscontact 2214, attached to resilient support 2216. All contacts 2210,2212 and 2214 are electrically connected to modifying means 2218 forenabling, disabling, or modifying the vibratory energy generated byhandpiece 2200. Modifying means 2218 may be an electronic circuitcontained within handpiece 2200, or in core body 2204, or alternativelymay be provided external to the handpiece, connected by wired orwireless transmission means, not shown, as known in the art.Alternatively, modifying means 2218 may merely enable and disable anenergizing circuit operative to power a vibratory generator withinhandpiece 2200. In either an electrical or electronic configuration, assleeve 2202 is urged in a direction “A”, contact 2214 will ultimatelyelectrically connect with contact 2210, closing a circuit or sending asignal to energize a vibratory energy generating circuit. As sleeve 2202is urged further in direction “A”, contacts 2210 and 2216 remainelectrically connected, contact 2214 moving in connection with resilientsupport 2216, which becomes compressed. As movement in direction “A”continues, contact 2212 ultimately electrically connects to contact2214, changing the circuit previously created by contacts 2210 and 2214,opening a circuit or sending a signal to deenergize a vibratory energygenerating circuit.

In this manner, if insufficient pressure is applied to a fastener of theinvention by end effector 104, vibratory energy will not be applied.Moreover, as excess pressure is applied to the fastener, vibratoryenergy will not be applied. Thus, handpiece 2200 may be operated toreliably apply vibratory energy only while an amount of force within apredetermined range is applied. While the circuit formed betweencontacts 2210, 2212 and 2214 has been described to control or signal ahard limit, that is, too little or too much force, it should beunderstood that it is possible to reduce or increase a vibratory signalbased upon excess or insufficient pressure, respectively, by usingpressure sensing transducers in place of one or more of contacts 2210,2212 or 2214, or by employing additional contacts.

It should further be understood that contacts 2210, 2212, or 2214 may bepositioned along an interface formed between overlapping portions ofsleeve 2202 and core body 2204. An electrical connection may be formedbetween sleeve 2202 and core body 2204, to convey one or more signals,and or to convey power to core body 2204, in a similar manner, orthrough the use of a self coiling wire 2208, as shown. Core body 2218may alternatively obtain power through the use of an attached battery,as described further herein. Additionally, resilient support 2216 may beattached to core body 2204, as opposed to sleeve 2202, withcorresponding changes to the circuit logic to achieve the aforedescribedcircuit effects.

In an alternative embodiment of the invention, resilient support 2216functions as a strain gauge, and transmits pressure information to amicroprocessor or gauge. Similarly, any or all of contacts 2210, 2212and 2214 may function as strain gauges. As such, transmitted informationmay cause the microprocessor to control operation of the device basedupon the pressure sensed. In this manner, it may not be necessary forcontacts 2210, 2212 and 2214 to establish and break contact with eachother, but rather, they may resiliently contact each other throughoutall or a portion of their relative movement, relaying relative pressuredata.

Battery Powered Vibratory Energy Generator

With reference to FIG. 62, a handheld or portable vibratory generatorhas a requirement for a substantial amount of current, at high voltage.In accordance with the invention, an inverter 2400 is provided toconvert the signal from a direct current battery 2424 into a suitablesine wave signal, and a step-up transformer 2402 is provided to increasethe voltage to an effective level.

In one embodiment multiple mosfet devices 2404, 2406 may be connected inparallel, advantageously provided in pair arrays, to provide for anadequate amount of current, wherein each pair 2404, 2406 increases theamount of current the circuit can provide. A control circuit 2414includes a microprocessor 2408, which controls a MOSFET driver 2416,which provides power to the mosfet array pairs 2404, 2406. To convertfrom the direct current of battery 2418 to the alternating currentrequired by a piezo stack or vibratory energy transducer, controlcircuit 2414 alternately switching power between MOSFET devices 2404 and2406, in order to produce an alternating current within the primarywindings 2420 of transformer 2402. This in turn induces an alternatingmagnetic field, which induces an alternating current in secondarywinding 2422. Control circuit 2414, advantageously further including adigital signal processor (DSP) 2410 for further signal modification,thus creates a wave form at the proper frequency and voltage forvibratory bonding of the invention.

Additional control circuitry may be employed, as known in the art, tomodify the signal parameters to enable precise bonding, as describedherein, including circuitry for voltage regulation, phase control, andvoltage and current detection and measurement.

Output 2412 of transformer 2402 is ultimately directed to a handpiece orpiezo stack (not shown), which will transform the electrical signal intovibratory energy.

To drive the circuit with adequate power, it is advantageous to use anefficient power storage medium, such as lithium ion batteries, which atthe current time are capable of sourcing up to 80 amperes at areasonable cost.

FIG. 87 illustrates a handpiece containing one or more batteries 3110,and an electronic circuit 3112 which may correspond to control circuit2414.

SONAR Measurement of Collapse

In another exemplary method, collapse of the fastener may be monitored,such as by the use of SONAR. Collapse is the distance a thermoplasticfastener or implant shrinks in height when vibratory energy is applied.For example, some thermoplastic fasteners have been found to shrinkabout 20 percent in height and increase 30 percent in width when bonded.For fasteners having two pieces, such as a cap and an anchor, theattenuation of the reflected vibratory waves changes as the two piecefastener becomes one piece. This change in attenuation may be monitoredto alert the surgeon or operator when the bond or staking is complete.Furthermore, a vibratory transducer could be used in conjunction withthe end effector to detect the change in acoustic impedance/attenuationof the site. This signal may be monitored by a microprocessor/controlleror data signal processor (DSP) and data may be automatically interpretedto indicate whether the bond was successful.

Another way of providing feedback of an effective bond is to monitor theEddy currents created by the movement of the end effector. As the endeffector vibrates, the linear motion creates a change in the magneticfield. By monitoring the travel of the end effector, the amount ofcollapse can be determined.

Booster/Attenuator

With reference to FIGS. 69 and 86-87, in another embodiment inaccordance with the invention, peak to peak motion, or amplitude of thevibratory horn or end effector 104 is controlled using an attenuator orbooster 3100, positioned after the piezo stack 3102. FIG. 69 illustratesdisplacement varying in relationship to the stack drive signal, whereina booster or attenuator alters the minimum and maximum displacement ofthe end effector. Booster 3100 comprises an input mass 3104 and anoutput mass 3106, sized relative to each other, with output mass 3106 ofa lower mass and smaller dimension, operative to result in an increasein vibratory frequency of end effector 104. While a booster 3100 isshown, it should be understood that an attenuator, not shown, islikewise adapted as known in the art to reduce an output frequency, withan output mass larger and or larger dimension than an input mass.

FIG. 86 illustrates a booster 3100 positioned exterior to a housing 3108of handpiece 100, whereas in FIG. 87, booster 3100 is positionedinternal to housing 3108. The invention contemplates that by positioningbooster 3100 within housing 3108, rigidity of booster 3108 may bereduced, as it is provided with additional support by housing 3108. Inthis manner, the overall weight and cost of handpiece 100 may bereduced. If the entire cost of handpiece 100 is sufficiently low,handpiece 100 may be designed for use in a single medical procedure andthereafter discarded, thereby removing a requirement that the device besterilizable (e.g. able to withstand steam and pressure), and furtherreduces the potential for cross contamination between patients.

FIG. 87 further illustrates a battery powered vibratory device inaccordance with the invention, containing one or more batteries 3110,and electronic circuit 3112 operative to produce the signal required forproduction of vibratory energy in accordance with the invention, asdescribed elsewhere herein. Contacts 3114 enable an electricalconnection for recharging the batteries. Alternatively, the batteriesmay be provided precharged in a single use device, wherein contacts 3114may be eliminated. Alternatively, an inductive coil, not shown, may beused to provide power, using techniques known in the art, for chargingbatteries 3110, or for powering the handheld device 100 whether or notthere are internal batteries 3110.

In contrast, the handpiece of FIG. 86 is provided with conductors 3116,operative to convey a required signal from a generator or controldevice, not shown. It should be understood that the device of FIG. 86may also be configured as battery operated as shown for FIG. 87; howeveronly one device is shown as such for brevity.

With reference to FIGS. 86 and 87, logic circuit 3118 is provided tocarry out computational calculations as described herein, and controlcircuit 3120 is provided to change an input signal as required togenerate a correct vibratory output at end effector 104. Alternatively,logic and control may be provided entirely by a connected generator, notshown.

In addition to booster 3100, control may further be achieved by thegenerator or logic circuit 3118 and or control circuit 3120 bymodulating the power, or amplitude, of the high frequency signal, asdescribed elsewhere herein. Buttons 3124 may be provided to commencebonding, stop bonding, toggle through options, or otherwise controlactions of the handpiece.

Booster 3100 may be replaced, as by a threaded or other mechanicalconnection to end effector 104, and piezo stack output shaft 3122. Tofacilitate booster 3100 selection, and to reduce the incidence of error,booster 3100 may be color coded, and may further be color coded to matchfasteners, handpiece 100, end effector 104, or other physical device orinstruction document properly associated with the use of booster 3100.Color coding may be used elsewhere when carrying out the invention, forexample between fasteners and single use handpieces, such as handpiece100 of FIG. 87, and fasteners and end effectors and horns.

Thermal Staking

Staking of the fastening device of the present invention could also bedone using thermal energy. The process for thermal staking is similar tothe one used for vibratory, except that it may not be necessary to tunethe system. The energy signal sent to the stake can be either AC or DC.To allow for longer heater life, a pulse width modulated (PWM) signalcould be used. The PWM signal allows for the energy to be rapidlyswitched on and off with a varying duty cycle proportional to the totalsystem energy needed for the staking environment.

Color Change

It is also contemplated that the material being bonded or staked may betranslucent or transparent, and a visual indicator within the materialcould indicate when the process is complete. For example, a pigment,dye, or other substance may be impregnated into the thermoplastic whichwhen subjected to vibratory energy the pigment or dye would be releasedindicating that the bond or staking is complete. However, as discussedelsewhere herein, certain pigments, particularly in high concentration,may adversely affect bonding; accordingly, appropriate testing must becarried out for each admixture. Alternatively, the material of thethermoplastic may have the characteristic of changing color as heat orvibration is applied for a predetermined time or a predeterminedfrequency and wattage.

Combined Therapeutic/Diagnostic Vibratory Generator

With reference to FIG. 63, in accordance with the invention, a vibratoryenergy generator 2500, advantageously a vibratory generator, includespower and logic circuitry 2522 for generating and controlling a signalwhich may be used to create vibratory energy, and is otherwise adaptedto perform diagnostic as well as therapeutic tasks. Diagnostic tasksinclude mapping or visualization of a target location. Informationgathered during the diagnostic phase can be used by the surgicalpractitioner to determine optimal settings for a subsequent therapeuticuse of the device, specifically including vibratory fastening asdescribed herein.

Generator 2500 may include separate connectors 2502, 2504 which arededicated to diagnostic or therapeutic purposes, respectively, or acombined connector 2506 may be used cooperative with combinationhandpiece 2508, described further below. Generator 2500 may further beprovided with any one or more of an integrated output display 2510,external display 2512, mouse 2514, or integrated keypad 2516. It shouldbe understood, however, that the range of integrated and external humaninterface devices known in the art may be employed in combination withthe invention. In one embodiment, any of the mouse controls, for examplebuttons 2518, 2520 may be used to switch between diagnostic ortherapeutic modes, wherein a transducer is caused to output diagnosticor therapeutic vibratory energy depending upon the button pressed,advantageously in combination with a mode selected with another humaninput device or the circuitry within generator 2500.

The diagnostic information may further be directed to a microprocessor,either within circuitry 2522, or external (e.g. within a personalcomputer) to generator 2500, either of which may include a DSP, whichwill then carry out or suggest optimal therapeutic settings to thepractitioner, which may then be communicated by output devicesassociated with the external microprocessor, or through human interfaceoutput devices connected to generator 2500.

Diagnostic information may include mapping information pertaining tostructures in the body which are not visible, including representativeimages of physiological areas of interest. Additionally, diagnosticinformation may include information pertaining to the environment inwhich fastening in accordance with the invention is to take place,including microclimate information, including temperature, humidity, orinformation relevant to the size of implant needed. This information maybe determined using calculations of the speed of travel of vibratoryenergy through various medium, and is particularly well understood withrespect to vibratory energy.

Referring now to FIG. 64-66, in one embodiment of the invention, avibratory energy generator is provided in a portable or handheld device2530, which produces vibratory energy for diagnostic purposes with anarray of crystals 2532, and for therapeutic purposes by a stack ofcrystals 2534, within a housing 2536 incorporating both arrays.

In one embodiment of the invention, crystals 2532 and 2534 arepiezoelectric crystals of ceramic with tungsten-bronze structures, butmay include any crystals, or any other transducer whether or notcrystalline, known in the art to generate vibratory energy fromelectricity, and electricity from vibratory energy.

Accordingly, a single microprocessor may advantageously be used tocontrol both crystal configurations 2532, 2534 based on separatealgorithms for each, and a medical practitioner may switch betweendiagnostic and therapeutic uses without switching to a different tool.

Housing 2536, shown, has a simple form, although it should be understoodthat housing 2536 may be ergonomically shaped to best fit the humanhand, or may be shaped in the manner of a gun, and may further includebuttons or other controls, not shown, useful for communicating withassociated equipment, such as generator 2500. Wire 2538, extending fromhousing 2536 and connected to each crystal array, extends to a generatorof vibratory energy, such as generator 2500. Alternatively, device 2530may be provided with its own source of battery power, as describedelsewhere herein, and may be wirelessly connected to a microprocessor ordigital signal processor which conveys signal information relevant tothe medical and bonding procedure undertaken.

It is advantageous to reduce the time required for most tasks during amedical procedure not only to reduce costs and the time required tocomplete the procedure, but also to reduce the time during which thepatient is subjected to discomfort or the risks of surgery, whichinclude prolonged anesthesia, increased bleeding, and additionalexposure to microorganisms. The instant invention reduces the timerequired to complete a procedure by enabling rapid generation ofaccurate data pertaining to the physical environment, the tissue orstructures to be fastened, the dimensions of a required fastener, andthe bonding parameters. Once this data is available, the device enablestherapeutic use of vibratory energy, including the bonding of fastenersas described herein, without a requirement to change tools.

Irrigation/Suction End Effector

With reference to FIG. 81, during vibratory bonding, the presence ofliquid or moisture can impact the performance and quality of the bond.One approach to ensuring a consistent and reliable bond, as describedherein, is to adjust the bonding parameters according to the amount ofobserved or measured moisture within the zone or area of bonding.Another approach in accordance with the invention is to remove moisturefrom the bonding area, by introducing an input stream of gas or liquid,or by applying suction/aspiration proximate the bonding site. In oneembodiment, a tube 3000 is attached to a vibratory end effector 104,wherein tube 3000 has a distal opening 3002 which serves as the inletfor aspiration, or conversely the outlet for a gas or liquid stream,opening 3002 positioned at a location near where bonding is to takeplace. A fitting or coupling 3004 may be provided at a proximal opening3008, to releasably attach tube 3000 to a source of vacuum or lowpressure, not shown. Tube 3000 is attached by any means known in theart, including for example adhesive 3006, brazing or welding, or one ormore resilient bands or screws. To avoid potentially damping a vibratorysignal, however, it may be advantageous to alternatively attach tube3000 to sheath 146, which surrounds end effector 104, but does notsignificantly inhibit vibratory motion.

In a further embodiment, an additional tube 3010 is provided, attachedto end effector 104, having like components relative to tube 3000,including a coupling 3012 at proximal opening 3014, and a distal opening3016. Tube 3000 or 3010 may be bent or shaped to direct opening 3002,3016, respectively. For example, as illustrated at 3018, tube 3000 isbent to direct opening 3002 towards a bonding site. In an embodimenthaving two or more tubes, at least one of tube 3000 or 3010 introducesan input stream of gas or liquid, and a second tube is operative to forman output stream to collect the gas or liquid via suction, together withany debris collected and carried therein. While tube 3010 is illustratedas being directly connected to end effector 104, it may alternatively beconnected to sheath 146, as outline above with respect to tube 3000.

An advantage of the aforedescribed embodiment is the removal of debrisgenerated during the bonding process, which may include flash formed atthe bonding periphery, as well as any other material or body tissue thathas vibrated loose or otherwise has become loose within or near thebonding area.

The first or second tube 3000, 3010 may be fastened to the outside ofthe vibratory end effector, as described with respect to FIG. 81, or mayalternatively be formed as one or more channels or pathways within theend effector, as may be seen in FIGS. 82-83, or a combination ofinternal and external pathways. FIG. 82 illustrates a single channel3020, having a proximal opening 3022, a coupling 3024, and a distalopening 3026. FIG. 83 illustrates two channels, 3020, 3040, channel 3040having analogous elements including proximal opening 3042, coupling3044, and distal opening 3046. It should be understood, however, thatchannels 3020 or 3040 formed within end effector 104 may impacttransmission of vibratory energy, and thus tuning may result indiffering parameters with respect to an end effector without channels,particularly if the channels are formed with a significant lengthtransverse to a longitudinal axis of end effector 104.

Liquids which may be passed to the body through tube 3000, 3010, 3020 or3040 (hereafter collectively tube 3000) include, for example, sterilesaline, therapeutic substances including the substances defined herein,injectable polymer, bio-graft material, radioisotope tagged liquid, livecells, or any other material as determined by a medical practitioner tobe of benefit to the patient. Similarly, gases passable through tube3000 include oxygen, nitrogen, carbon dioxide, or any other gasdetermined by a medical practitioner to be of benefit to the patient.Flowable powders or particulates may also be passed through tube 3000,as determined to be of benefit.

In the embodiments of FIGS. 81-83, switches or controls for activatingan input or output stream may be provided on a handpiece to which endeffector 104 is connected, for example handpiece 100, or on a footswitch or hand operated remote, not shown, or the input or output streammay be activated by voice control.

Referring now to FIG. 85, the end effector 104 of FIG. 83 is showndisposed within a cannula 3200. In this manner, materials introducedthrough tube 3020 may be confined within a specific area defined bycannula 3200. Moreover, additional materials may be introduced throughcannula 3200, and these materials may also be confined within cannula3200. Thus, materials may be introduced to an area of fastening whichhave a reduced impact on surrounding body tissue. Additionally, benefitsof a cannula, or expanding cannula, may be attained, including themaintenance of potentially intruding tissue at a distance away from afastening site.

In one embodiment of the invention, a stream introduced through tube3020, or alternatively through cannula 3200 (indicated by arrow “A”) maydislodge tissue cells 3202 which are intended to be harvested forsubsequent use, or which are harmful and are intended to be removed forthe health of the patient. For harmful tissues, radio frequency may beemitted as described with respect to FIG. 84, to destroy or loosenharmful cells. Alternatively, a therapeutic substance may be used toloosen or dislodge harmful cells, the substance admitted at “A” orthrough tube 3000. Further, material may be admitted at “A” or throughtube 3020 under pressure. In particular, material may be admittedthrough tube 3020, for example, at sufficiently high pressure to have asignificant mechanical effect on exposed tissue, wherein firmly anchoredtissue or other matter may effectively be dislodged. Moreover, vibratoryenergy may be applied by end effector 104 to contribute to a looseningeffect. Loosened material may be removed by suction, as through tube3040, or through a flow upwards in a direction opposite to arrow “A”, toa point exterior of cannula 3200. Additionally, an aspirator, not shown,may be employed.

It should be understood that the devices of FIG. 81 or 82 mayalternately be used in conjunction with cannula 3200 as described, oralternatively, any of the other devices of the invention which mayadvantageously be admitted to the body through a cannula.

Radio Frequency End Effector

With reference to FIG. 84, in another embodiment, one or more radiofrequency transmitting antenna 3050 are provided proximate the distalend of end effector 3054, operative to break down or destroycontaminants within the bonding area, including moisture orparticulates. Shielding, not shown, is appropriately placed in order tosafeguard any nearby body tissue or material which might be vulnerableto stray transmissions. One or more wires 3052 connect antenna 3050 to aradio frequency signal generator, not shown. The RF embodiment of FIG.84 may be combined with other end effector types, including those ofFIGS. 81-83.

Testing

The previously described methods for providing positive feedback to theoperator included the use of measurements and/or computers. Anotherpositive feedback system is provided which relies on physical force.When two objects are fastened to each other, it is common for thetechnician or mechanic to pull or tug on the assembly to ensure theparts are securely fastened. This common technique may apply to thethermoplastic system of the present invention. Once a fastener or otherimplant is vibratory bonded or staked, the surgeon can apply a quick tugon the assembly to verify the bond or staking was completed as intended.

In accordance with an embodiment of the invention, a frame is providedwith an aperture through which a fastener body may pass, sized toprevent passage of a fastener head. The device may thus test the holdingstrength of a distally bonded connection, as well as proximal bondincluding a head formed with vibratory energy. A strain gauge, springscale, or other suitable measuring device is connected to the frame, anda force is applied in a direction away from the fastened connection. Theresults are observed and recorded, together with the parameters underwhich the connection was formed and tested.

FIGS. 11A and 11B illustrate a feedback instrument 160 for performingsuch a physical positive feedback check. An end effector 162 includes apost 164 which emits vibratory energy. A thermoplastic fastener 166 isplaced on the end effector 162 with the post 164 in a bore or receptacle168 of the fastener 166. After emitting vibratory energy and bonding orstaking the fastener to an implant or tissue, the surgeon may actuate abiasing prong or prongs 170 from the post 164 of the end effector whilethe post 164 is still in the fastener 166. In a stored configuration,the prongs 170 are positioned within the post 164. In a deployedconfiguration, the prongs 170 extend radially from the post 164 by theactivation of a handle, switch, or button. The extended prongs 170 digslightly into the material of the fastener 166 so that the surgeon maynow pull or tug on the instrument 160 proximally to verify that thefastener 166 is securely bonded or staked in place. Additionally, theprongs 170 and/or post 164 may include a strain gauge or other forcemeasuring device to measure and display to the surgeon how many poundsof pull strength is being put on the fastener.

To aid in determining the exact conditions under which fastening wasaccomplished, an electronic circuit separately measures the powerconsumed in tuning the vibratory instrument, and performing the bonditself. This data is used, together with other parameters, to enable theproduction of a secure and reproducible bond.

Fastening Procedures

When two dissimilar materials need to be bonded together, the bondingmay be performed outside the body, such as during the manufacturingprocess or within the operating room. This is done to avoid damage tosurrounding tissue caused by the heat required to bond the dissimilarmaterials to each other. Then, once implanted, further bonding may bedone within the body to bond like thermoplastics creating the desiredimplant configuration. For example, a spacer made of PEEK may be joinedto a metallic implant outside the body. The spacer and implant may beplaced in the body, and the PEEK may be bonded with another PEEK elementinside the body so that there is a PEEK to PEEK bond. The metal implantmay be the load bearing surface or the bearing point, while the PEEK toPEEK bond provides for the fastening and stabilization of the implant.

Staking

Although the above-discussion emphasizes bonding or welding, the presentinvention also contemplates staking in most situations as an alternativeor supplement. Staking generally involves the mechanical interlock ofdissimilar materials. Staking is the process of melting and reforming apiece, such as a stud, to mechanically lock a material in place. Itprovides an alternative to bonding when two parts to be joined are madeof dissimilar materials that cannot be bonded or simple mechanicalretention of one part relative to another is adequate.

The advantages of staking include short cycle time, the ability toperform multiple staking with one end effector. The most common stakingapplication attaches metal to plastic. A hole in a metal part isdesigned to receive a plastic stud. An end effector with a contoured tipcontacts the proximal end and creates localized frictional heat. As thestud melts, light pressure from the end effector reforms the head to theconfiguration of the end effector. When the end effector stopsvibrating, the plastic solidifies and the metal and plastic parts arefastened together.

Thus as set forth in the prior art, which is not in the medical field,staking using vibratory energy causes thermal deformation at the site ofthe end effector and the near end of a polymer. As the inventors havepreviously defined for bonding, vibratory bonding can be near field(less than ¼ inch from the end effector) and far field (greater than ¼inch from the end effector). Staking, as defined in the prior art is allnear field. To date, no one has performed distal or far field staking.This is where the mechanical deformation occurs at a site away from thevibratory horn or end effector. The staking can occur, not at thetrailing edge of the implant, but along the implant surface, or at thefar end of the implant, where the implant can be bonded to anotherimplant mechanically, particularly if it is a dissimilar implant. Thedistal staking of the invention causes deforming and melting tomechanically interlock into a like or dissimilar material. In accordancewith the invention, the horn does not necessarily reform or change asurface with which it comes in contact, as is disclosed in the priorart.

FIGS. 21-24 illustrate some uses of vibratory staking for implants andtissue fastening. In FIG. 21, a PEEK (or other polymer) tack 4000 havinga proximal end similar to the anchor in FIG. 22 is used to couple twomaterials together, in this case two porous metals 4002, 4004. Afterstaking, the proximal end assumes the shape 4006 of the end of the endeffector. Additionally, the distal end 4008 of the tack could be securedto porous metal using vibratory energy.

FIG. 22 shows a polymeric anchor 4010 prior to staking with thedomed-shape end effector. The anchor 4010 is illustrated as threaded, asa means of securing the base to the body or other implant. However, thebase may be connected to the body or another implant using vibratoryenergy in accordance with the invention, or may otherwise be securedusing means known in the art. Post 4014 on the proximal end of anchor4010 can be used to pierce one or more objects, in this example softtissue 4016, holding it in position relative to 4012. The objects mayalternatively be bound by passing the end of post 4014 through anaperture or gap in each of the objects to be staked, or by forming thegap or aperture with post 4014. The tip 4018 is then formed by stakingusing end effector 104. In this example, end effector 104 is curved ordome shaped, and is operative to form a complementary dome shape on theend of post 4014. Generally, however, bondable material on the end ofpost 4014 will expand outwards, enlargening the end of post 4014. Inthis manner, the end of post 4014 becomes larger than the gap in theobjects. It is desired for the end of post 4014 to expand to a size atleast larger than the gap in the object closest to the end of post 4014,in order to at least secure the top-most object. As such, objects uponpost 4014 are secured within the body, bounded by secured base on oneside, and expanded post 4014 on the other, and are thus staked. Ifneeded, the post can be trimmed (either mechanically or by shearing offwith the vibratory energy) before staking. A load bearing surface 4020may be added before tip 4018 is formed, if additional support is deemedbeneficial.

In FIG. 23, a fracture fastening plate 4100 is secured with screws 4102having tips 4104 projecting above the top surface of plate 4100. Screws4102 can be placed through holes in plate 4100, and tips 4104 staked tosecure plate 4100 to bone 4012. Screws 4102 can be inserted through theplate at angles other than ninety degrees. In another embodiment, screws4102 are first threaded into bone 4012 and then plate 4100 is insertedover the proximal tip.

FIG. 24 shows that two implants can be joined with far-field bonds 4014,then formed at the end effector to seal over bone or implant. Thenear-field staking 4016 should not adversely damage or affect thefar-field bond 4014, as each bond is tuned for the particular locus ofvibration desired.

FIGS. 25A-C show another embodiment of an anchor 400 particularly wellsuited for staking to a plate 402. Anchor 400 has a body 404 withthreads 406 for fastening to bone. As shown in the testing jig, afteranchor 400 is secured to bone, the plate 402 is inserted over head 408of anchor 400. If needed, head 408 can be trimmed or otherwise cut tosize. A staking end effector 410 is placed on head 408. Upon activationof the vibratory energy, head 408 deforms to the shape of the tip of endeffector 410 (in this case, domed shaped) to secure anchor 400 to plate402.

FIGS. 26A-C show an alternative anchor 422 configuration analogous tothe configuration shown in FIG. 23, however plate 402A has an elongatedslot 420 enabling a variety of fastening positions.

FIGS. 27A-27C show another staking application of the invention. Inparticular, a standard metallic polyaxial screw/rod system 4120 has beenmodified to include holes 4122 intersecting both the saddle 4124 thatholds the rod 4126 and pedicle screw head 4130 (not visible) and thelocking screw 4128 used to maintain the desired angle of the pediclescrew 4132. A tack 4134, including bondable material at least on itsexterior surface, is inserted into holes 4122, and then staked or bondedusing vibratory energy in accordance with the invention. In this manner,the material of tack 4134 flows into the threads 4136 between saddle4124 and locking screw 4128, effectively preventing loosening.

FIGS. 28A-28C show that the staking concept can be applied to angulatedscrews, typically used in spinal applications. Specifically, screws thatcan be placed at an angle through the plate and then staked in place.This embodiment is discussed further within a discussion of spinalfixation, herein.

In a final staking application, FIG. 30 shows that the end effector canbe used as the implant itself. Specifically, one application would beinserting a metal pin into a PEEK (or other thermoplastic material) rod.Typically, using a metal pin would create arcing and sparks due to themetal on metal contact. In order to minimize this effect, a metallic pinis rigidly attached to an end effector. Although a connection similar toa BNC connection is shown, any quick release mechanism could be used.

For example, a PEEK (or other polymer) anchor/fastener, or tack may beused to couple two materials together, in this case two porous metals.After staking, a proximal end assumes the shape of the end of the endeffector. Additionally, the distal end of the tack is fastened to porousmetal, such as may be found on an interior face of an implant, securedusing vibratory energy.

Initially, the anchor is threaded or otherwise secured to the bone. Apost projecting away from the bone on the proximal end of the anchor canbe used to pierce soft tissue to be attached, holding it in positionrelative to the bone. The tip is then formed into a cap by staking, withor without an interposing element between the soft tissue and the capformed at the proximal end of the post. If needed, the post can betrimmed (either mechanically or by shearing off with vibratory energy)before staking. In this manner, a plate or other structure can beattached using two or more tacks.

Fastening into Existing Cement/Adhesives

With reference to FIG. 44, in an additional embodiment in accordancewith the invention, one or more fasteners 1000 are provided to embedwithin, and thereby become securely fastened to, previously hardenedbondable material 802, such as bone cement, in vivo. Fastener 1000 maybe any of the fasteners which may be connected to bondable material withvibratory energy, as described herein. This method is advantageouslyemployed, for example, to repair bone fractures, secure and resecureimplants, repair periprosthetic fractures, and to secure or repairdental devices and implants. For example, a medical practitioner mayobserve a lucent line progressively developing as an implant loosens,indicating a separation between body tissue and the implant. In theprior art, revision surgery would be required in order to remove and orre-cement the implant. In accordance with the invention, a tack, pin,bar, rod, plate or other fastener 1000 may be inserted into the body,and fastened to bondable material 802, implanted earlier, through theapplication of vibratory energy, said energy advantageously includingultrasonic energy. As discussed elsewhere, herein, the distal portion1002 of the fastener is caused to resonate and vibrate in contact withthe bondable material 802, locally heating the latter to enable adhesionto fastener 1000. The fastener thus may serve as an anchor point insubsequent steps to re-secure the implant.

With reference to FIGS. 40-41, embedded fastener 800 has been embeddedwithin bondable material 802 within the body. As is the case with allillustrations herein, FIGS. 40-41 are not necessarily to scale, butrather drawn to simplify understanding of the invention. In the exampleshown, bondable material 802 is found surrounding acetabular replacementprosthetic 880, implanted within femur 882, and locking fastener 840 hasbeen secured to embedded fastener 800. In some procedures, it may benecessary to first drill a hole or remove body tissue in order to accessthe implanted bondable material 802 with embedded fastener 800. Onceimplanted, embedded fastener 800 may serve as a convenient attachmentpoint for further implants or fasteners, or may simply lock the adhesiveand bonded prosthetic 880 in position relative to bone 882. In theexample shown, locking fastener 840 attaches unsecured member 884relative to bone 882. Unsecured member 884 may be, for example, aprosthetic, a living tendon, an allograft, or any other object asurgical practitioner may wish to secure in a specific location.

Fasteners securable to implanted bone cement include the materialsdescribed in this specification, including as examples PMMA, metal,metal at least partially coated with PMMA or acrylic, PEEK(polyetheretherketone), and acrylic, or can be a composite includingresin, and or carbon fibers. A thin coating of PMMA or acrylic, as smallas several microns, contributes to forming a secure bond with bonecement within the body. Bonds may additionally be formed betweendissimilar adhesives.

An initial bore may be made in the bone cement to aid alignment, totemporarily retain the fastener, or to increase the surface area forfastening. The fastener may be placed in an intended location through,for example, intramedullary, percutaneous, or retrograde approaches.

With further reference to FIG. 44, a brace 1004 is positioned along bone882. Alternatively, brace 1004 may be positioned upon the surface of theskin, or at any point between the bone surface and the skin, accordingto the requirements of the surgical procedure. Further, brace 1004 maybe placed within the bone, for example in an intramedullary canal.Fastener 1000 is secured to bondable material 802, or a porous surfaceof implant 880, in a manner described herein, for example through distalvibratory fastening. A cerclage wire 1006 may be employed as known inthe art, to provide further stabilization, in combination with fasteners1000. A head portion 1012 may be provided upon fastener 1000, or may beformed using vibratory energy.

In an embodiment of the invention, one or more of fastener 1000 passesthrough and stabilizes brace 1004 with respect to bone 882, on a firstside of bone damage 918A. Brace 1004 extends to a point distal to thefirst side of bone damage 918A, for example to a bone 882 portion on anopposite or second side of damage 918A. Brace 1004 is further secured onthe second side of damage 918 a, and the two sides of damage 918A arethus secured relative to each other, enabling healing or repair ofdamage 918A during a period of reduced mechanical disturbance. Fasteners1000 may be used to stabilize brace 1004 on the second side of damage918A if embedded bondable material is present on the second side ofdamage 918A, for example embedding into bondable material at 802A.Capped fasteners 1008 are shown, passing completely through both sidesof bone 882. Caps or heads 1010 may be formed using vibratory energy asdescribed in this specification, or capped fastener 1008 may be passedthrough 882, as by piercing bone 882 with a pointed end of the fastener,or by forming openings in bone 882 before passing the fastener throughbone 882. Alternatively, capped fastener 1008 may be provided in theform of a drill bit, with caps formed before or after implantation usingvibratory energy, as described in this specification.

In yet another embodiment of the invention, a fastener 1008 is passedthrough bone 882, contacting bondable material 802 along at least onearea of shaft 1014 of fastener 1008. Through tuning, described in thisspecification, vibratory parameters are established which promotevibration in a contact area between shaft area 1014 and bondablematerial 802. Accordingly, fastener 1008 is bonded to bondable material802 at shaft area 1014. Additional stabilization is optionally providedby passing fastener 1008 through another cortical layer of bone 882, andin the example shown, an area on an opposite side of damage 918A.

Referring now to FIG. 96, body tissue 3700, in the example shown, atendon, is fastened to body tissue 3702, in the example shown, a bone,using fasteners 1256 (of FIG. 50) in accordance with the invention.While fastener 1256 is shown, other fasteners of the invention may beused, including fastener 800, or the fasteners of FIGS. 46D-46H, forexample. Fastener 1256 extends through body tissue 3700, and is fastenedto the surface of tissue 3702, which advantageously has been providedwith a roughened or porous surface, or a surface with at least onecavity therein, in or upon which softened or melted material of fastener1256 may attach.

Fastener 1256A penetrates body tissue 3702, either by being driventhrough tissue 3702, or by passing through an aperture formed withintissue 3702 in advance. Anchor 3704 of bondable material has beeninjected into, or otherwise been positioned within body tissue 3702, sothat it is adhered within tissue 3702. Any of the bondable materials asdescribed herein may be used, including biocompatible forms of n-butylmethacrylate, or poly-butyl-methacrylate (PBMA), of suitable strength.Anchor 3704 may further be advantageously of a biodegradable material.Fastener 1256A is thus caused to pass through tissue 3702 to contactanchor 3704, whereupon distal fastening in accordance with the inventionmay be carried out. In this manner, anchor 3704 serves to bind a distalside 3706 of tissue 3702 to a proximal side 3708, relative to fastener1256A. In this manner, fracture 3710 is maintained in a positionadvantageous for proper healing. In the embodiment shown, fastener 1256Aserves both to affix tissue 3700 and secure fracture 3710; however itshould be understood that one or the other purpose may be carried outalone. For example, fastener 1256A need not pass through tissue 3700 inorder to secure fracture 3710, or alternatively, may secure tissue 3700as shown, in the absence of fracture 3710.

End Effector for Fastening into Adhesives

Further, the end effector can be used as the implant itself.Specifically, in one embodiment of the invention, a metal pin, screw, orother engagement shape is inserted into a thermoplastic (e.g. PEEK) rod,the pin itself attached to an end effector. The metal pin must be firmlyattached, or formed integrally with the end effector, to avoid creatingarcing and sparks due to metal on metal contact between the pin andeffector. For removable pins, a release mechanism is provided.

In accordance with the invention, an end effector having a distal tipformed or attached thereto is inserted into a medullary canal in a longbone, and affixed into adhesive through the use of vibratory energy, asdescribed in this specification. The end effector is then removed fromthe remainder of the vibratory energy generating device, wherebyconnection means at a proximal end may be used to secure the endeffector within the bone, or to body tissue to be attached, or toanother implant.

With reference to FIGS. 41-43, an end effector 900 operative to transmitvibratory energy, for example ultrasonic energy, is passed into thebody, to contact a bondable material 802 within the body. The endeffector may be provided with a separable distal end portion operativeto transmit vibratory energy to the bondable material, such as, forexample, fastener 800 of FIG. 32A. Alternatively, the end effector maybe provided with a shaped distal end 902 operative to enter bondablematerial 802. In one embodiment, end effector 900 is replaceable andselectable by the practitioner to best pass through the body or enterbondable material. End Effector 900 may be removed or replaced, forexample, at a threaded or other mechanical connection 906 proximate ahandpiece 908.

With reference to FIG. 42, an end effector has been passed into theintramedullary canal of bone 882 in a body, in the example shown, afemur. It should be understood, however, that the dimensions of endeffector 900, together with any attached fastener or shaped end, isselected to fit within the particular body space contemplated by thesurgical procedure, which may include for example soft tissue space, ora location proximate the spine or skull. Bondable material may includeany of the materials described in this specification, however in theexample shown, material 802 is bone cement, previously implanted toretain hip replacement prosthetic 880.

Once end effector 900 has been secured to bondable material 802,handpiece 908 may be removed, exposing a portion of mechanicalconnection 906 at a proximal portion of the end effector 900. A proximalfastener 910 is then mechanically attached to mechanical connection 906,as by threading. Retaining means 912 are provided for affixing proximalfastener 910 to the body.

In the example shown, retaining means 912 comprise a flange in corticaltissue of bone 882. Proximal fastener 910 is shaped with a cooperatingflange 916, sized to be retained by retaining means 912. In this manner,once a mechanical connection is made between proximal fastener 910 andmechanical connection 906, a compressive force is established betweenretaining means 912 and embedded shaped distal end 902, secured withinbondable material 802. If proximal fastener 910 and mechanicalconnection 906 are threaded, the amount of compressive force isadjustable based upon the amount of threaded overlap. Retaining means912 may alternatively include an additional implant, for example a plateor pin (not shown), or an arthroplasty component 920, having an areasized and dimensioned to engage proximal fastener 910, and to therebytransmit a force applied to fastener 910 to the body.

Compressive force may be employed, for example, to bring togetherportions of body tissue, such as portions separated by trauma ordisease, or that have been separated in the normal course of a surgicalprocedure. For example, in FIG. 41, a region of bone damage 918, such asa fracture or diseased bone area, is shown prior to application of acompressive force as described, and in FIGS. 42 and 43, the fracture hasbeen approximated by compressive force.

With further reference to FIG. 43, arthroplasty component 920, in thiscase the articulating surfaces of the medial and lateral condyles andthe trochlear groove, are retained upon bone 882 at least by endeffector 900. Mechanical connection 906 passes at least partiallythrough a portion of component 920, and proximal fastener 910 isconnected thereto at mating portion 912A to secure component 920 ontoend effector 900. In the example shown, a portion 922 of component 920containing a single condylar surface and the trochlear groove isfastened directly to end effector 900, and a remaining condylar surfaceportion 924 is attached to portion 922.

Fastening into Implanted Device

As described elsewhere herein, implants and fasteners in accordance withthe invention are secured within the body, and then serve as attachmentpoints for further implants or fasteners. With reference to FIG. 61, anadditional embodiment of the invention includes an implant formed inparts, including a base 2300 attached within the body through connectionto body tissue or another implant, using apparatus and methods of theinvention, or using means known in the art. Base 2300 includes a surface2302 that may be smooth, but in accordance with the invention, isadvantageously provided with an irregular surface, such as a porous orroughened surface, or a surface having one or more cavities 2304 intowhich a bondable material may enter and thereby lock to the surface.

Mating portion 2306 engages base 2300 along mating surface 2308. Inaccordance with the invention, mating surface 2308 includes bondablematerial along at least a part of the surface which contacts surface2302. Base 2300 and mating portion 2306 are placed in apposition,whereupon vibratory energy, advantageously combined with pressure, isapplied to form a bond between surface 2302 and mating surface 2308, asdescribed elsewhere herein.

In the embodiment shown in FIG. 61, however, a vibratory horn 2310 isshaped to conform to an inner surface 2312 of mating portion 2306. Inone embodiment, horn 2310 is a portion or the entire implant intended tobe left in the body after a surgical procedure, and is connected to asource of vibratory energy (not shown) when horn 2310 is used to bondmating portion 2306 to base 2300. In this manner, vibratory energy isuniformly distributed throughout the region of intended bonding.Moreover, if inner surface 2302 is additionally formed with bondablematerial, or the entire mating portion 2306 is formed of bondablematerial, ideal conformance may be obtained on both sides of matingsurface 2308, between horn 2310 (the implant) and base 2300. This isadvantageous for smooth joint replacement movement.

After application of vibratory energy, advantageously ultrasonic energy,mating surface 2308 is firmly fixed to irregular surface 2302; however,if horn 2310 and inner surface 2312 are sufficiently smooth, a glidinginterface is created therebetween. Similarly, if it is a goal of havingmating portion floating between horn 2310 and base 2300, a smoothsurface may be provided for surface 2302. Further, it should beunderstood that a heat meltable surface may be additionally providedupon surface 2302, and mating surface 2308 may alternatively be providedwith the irregular surface described above.

In the example shown in FIG. 61, base 2300 and mating portion 2306 areshaped to function as a replacement for an acetabulum, however it shouldbe understood that any implanted shapes may be connected as describedherein. For a hip replacement, vibratory energy may be applied to aportion of the implant proximate horn 2310, of sufficient energy tocause the required melting or softening as described above.

Distal Fastening/Retrograde Approach

In accordance with a further embodiment of the invention, vibratoryenergy is applied to cause thermal deformation distal to the site ofapplication of the end effector. In this application, the mechanicaldeformation, especially in dissimilar materials, occurs at a site awayfrom the vibratory horn or end effector. The staking or bonding canoccur not at the trailing edge of the implant, but along the implantsurface or at the far end of the implant where the implant can bemechanically bonded to body tissue, implanted cement, or anotherimplant, particularly if it is a dissimilar implant.

Distal fastening is accomplished by reducing significant vibration at aproximal end of a fastener, and tuning for vibration at a distal end ofa fastener, or alternatively, an intermediate portion of a fastener. Thevibratory horn may be releasably connectable fastened to a source ofvibratory energy, as by threading or twist lock engagement or othermechanical means, thereby damping vibration at a point of connection,and enabling a transfer or transmission to a distal end of the horn. Thereleasable connection is used, for example, where it is intended toleave the horn within the body, or simply to discard the horn after use.Alternatively, the vibratory horn may simply be in firm contact with theend effector or source of vibratory energy, in order to transmitvibratory energy at a distal end. By establishing a firm contact, it ispossible to prevent generation of large quantities of heat at the pointof contact. In particular, sufficient heat to substantially soften thewelding horn at a point of contact can be avoided, should the weldinghorn contain bondable material.

In one embodiment, the end effector itself is fastened. In thisembodiment, where the end effector is elongated, a point of fastening isinherently distal from a body surface, or an entry point of the endeffector.

With reference to FIG. 46G, in an alternative embodiment, assembly 1240includes an end effector 1242 comprised of or at least partially coatedwith a bondable material 1244. After assembly 1240 is attached usingvibratory energy, end effector 1242 may be cut to a desired length.Fasteners 46D, 46G and 46H are advantageously, though not necessarily,elongated, so that they may pass through body tissue with a minimum ofdisplacement thereof, to reach a point of fastening.

In a further embodiment, with reference to FIG. 46H, an attachablefastener 1250, which includes bondable material 1252 is secured to theend of an end effector, wherein vibration at the attachment isdiscouraged, as by a sufficiently firm, secure attachment, for examplethreading 1254 (shown in cross section), or adhesion. In this manner,vibration may be tuned to occur at a distal end 1256 of fastener 1250,and not at a point of attachment 1258 between fastener 1250 and endeffector 104. Accordingly, the fastener now serves as a vibratory horn,whereupon it is used to generate heat at a distal point of contact. Ifthe contact surface contains bondable material, that material may besoftened. If the fastener includes bondable material at the point ofcontact, that material may also be softened by heat produced byvibration at the contact area. If the bondable material of the fastenerand the contact surface are the same or sufficiently similar, weldingmay occur, whereupon the fastener and contact surface become bondingwhen the materials cool. If the materials are different, the twosoftened surfaces may mix, or lock to each other mechanically aftercooling.

As the fastener has passed through body tissue, it is frictionallyengages therewith, or may additionally be affixed using methods of theinvention or prior art methods of attachment. In this manner, thecontact surface is further stabilized within the body through beingbonded to the fastener.

Referring now to FIG. 47A, an implant 1400, in this example a tibialarthroplasty prosthesis, has a surface 1404 onto which a fastenerincluding bondable material may deform and adhere, in order to form abond therebetween. Fastener 1250 is shown extending from the undersideof implant 1400, through bone 1402. Prior to forming cap or head 1010,in a manner described herein, a hole is formed in bone 1402, or fastener1250 is driven, pushed, or drilled into bone 1402, until distal end 1256is proximate implant 1400. In the example shown, cement, adhesive, orbondable material 1206 has been applied to the underside of implant1400, either in a previous procedure, or in the same procedure duringwhich fastener 1250 is affixed. If bondable material 1206 is present, itmay be melted by distally applied vibratory energy, as described above,to enable distal end 1256 to reach implant 1400. Once distal end 1256 isin contact with implant 1400, vibratory energy is applied to create heatat a contact area between fastener 1400 and distal end 1256, wherebydistal end 1256 deforms and flows onto a surface of implant 1400, towhich it adheres.

To improve bonding, at least a portion of the surface of implant 1400 isadvantageously provided with a rough, porous or irregular surface, or atleast one surface cavity into which softened material of fastener 1250may flow or be urged, as by pressure acting in the direction of thebond. Upon cooling, distal end 1256 is bonded to implant 1400, the bondstrength improved due to either or both of an increased surface area ofcontact, or mechanical interlock with the irregular surface of fastener1400.

Fastener 1250, in one embodiment, is sized so that sufficient materialremains exposed beyond the surface of bone 1402, wherein cap 1010 may beformed, as described herein. Alternatively, fastener 1250 may be cut, aswith a knife or saw, either flush with the surface of bone 1402, as maybe seen for example in FIG. 47C, or may be provided with sufficientexcess material to form cap 1010, as shown in FIG. 47A.

Distal fastening in accordance with the invention is advantageouslyemployed where a retrograde approach, such as that illustrated forfastener 1250 in FIG. 47A. A retrograde approach may be the onlyfeasible or safe approach to a fastening site, or may simply be easierthan an antegrade approach. A further advantage, as can be seen in theillustration, is that a surface of the implant positioned in fixedcontact with body tissue may be fastened, while an articulating surfacemay remain free of fasteners.

With further reference to FIG. 47A, fastener 1240 extends through bone1402 at a downwards angle towards the interior of bone 1402, withrespect to the proximate end of bone 1402. A distal end 1260 of fastener1240 has been distally fastened as described herein. A proximal end 1262extends from bone 1402, and may be cut at a level flush with theexterior of bone 1402, or at least a part of the extending portion maybe formed into a cap 1010. Alternatively, proximal end 1262 may be usedas a stake for fastening body tissue or other implants. In FIG. 47A,fastener 1264 is fastened to implant 1400, in this example embedded inbondable material 1206. Alternatively, fastener 1264 may be fastened toimplant 1400, as described for fastener 1240, above, or fastener 1264may be mechanically connected to implant 1400. Fastener 1264 isadvantageously angled to promote the secure retention of stakedmaterial. In the example shown, a tendon 1268 is staked, and fastener1264 is disposed at a neutral angle with respect to the proximal end ofbone 1402. Further, a reverse angle may afford additional stability andstrength of fastening, wherein fastener 1264 is angled upwards towardsthe interior of bone 1402 with respect to the proximal end of bone 1402.Fastener 1264 has a cap 1010 formed using the application of vibratoryenergy applied to the proximal end 1262 of fastener 1264, although othermeans of securing staked materials may be employed, such as by applyinga mechanical fastener.

FIG. 47B illustrates a method of attaching an articulating surface inthe prior art. Note that prior art implant 1410 must be formed in atleast two parts 1412, 1414, due to the requirement of first installing afastener 1416 through implant portion 1414 into cortical bone 1418, andthen installing implant portion 1412 over fastener 1416.

In contrast, implant 1400 of the invention may be formed as a singlepart, or at least the articulating surface 1420 may be integrally formedwith a portion 1422 which extends into bone 1402, thus presenting fewerpoints of potential failure, and providing a more stable and durableimplant.

Referring now to FIG. 47C, a retrograde and distally fastened fastener1440 is additionally connected to an implanted bone graft, or boneaugment 1442, thereby providing primary and or secondary stabilizationfor augment 1442. Augment 1442 may be implanted, for example, to replacediseased or damaged bone. In this manner, an articulating surface 1444as well as an adjoining bone augment 1442 may be secured by a singlefastener 1440, or a series of fasteners. Fastener 1440 may be distallybonded to both augment 1442 and the device 1446 bearing articulatingsurface 1444. Fastener 1440 may also pass through augment 1442, forexample through a bore preformed in augment 1442. Augment 1442 may becomposed of any material or combination of materials suitable for itsintended function, including metal, plastic, ceramic, alloys, moldablematerial including adhesives, as well as porous forms of thesematerials. Augment 1442 may additionally comprise cartilage graftmaterial.

The retrograde approach of the invention may be facilitated through theuse of a cannula, or an expanding cannula, such as is disclosed in U.S.Pat. No. 6,814,715, incorporated herein by reference, and relatedpatents cited therein. Retrograde examples include fastening anacetabular replacement from behind the cup, fastening a tibial bearingsurface replacement from a point below the bearing surface, andfastening a hip replacement implant from the femur body or distal end ofthe femur. Like examples are contemplated for the smaller analogs of thearm. Retrograde approaches may also be used in fastening or repairingbones of the hands, feet, skull, and spine.

With reference to FIG. 47D-E, one or more of clamp 1450 may be used inaccordance with the invention to position and or retain implant 1400 ina location for fastening. This is particularly advantageous where afastener of the invention is distally fastened to implant 1400, withoutthe use of an intervening adjustable mechanical coupling, such as thatdescribed for fastener 840, herein. In the illustration, a c-clamp typeof claim 1450 is shown, however any suitable clamp may be used, providedexposure is maintained for installing a fastener of the invention, andfor applying vibratory energy thereto. In FIG. 47E, fastener 1240 hasbeen installed, and clamp 1450 has been removed.

With further reference to FIGS. 47D-E, a fastener 1460 has been distallybonded to implant 1400. Fastener 1460 is formed in a manner illustratedfor fastener 1250 in FIG. 46H, however a cap 1468 is formed or attachedin advance of installation. In the use of this embodiment, it may not bepossible to precisely determine the length of a proximal portion 1462extending beyond the surface of bone 1402. Accordingly, the inventionprovides a spacer 1464, shaped to fill a portion of a space formedbetween cap 1468 and bone 1402. Spacer 1464 is further formed with anopening, so that a spacer 1464 having a desired width may be selectedafter fastener 1460 is inserted into bone 1402. An amount of fastenercollapse, described in this specification, is calculated or estimated,and a spacer 1464 is selected so that an amount of free space remainsbetween cap 1468 and bone 1402, corresponding to the expected amount ofcollapse. Accordingly, after fastening, fastener 1460 transmits a forcethrough cap 1468 and spacer 1464 to bone 1402. Further, fastener 1460 isstabilized in firm connection to bone 1402. Moreover, body tissue maynot enter a space between cap 1468 and bone 1402, either through tissueingrowth or through tissue movement. It should be understood that spacer1464 may be employed in any fastening application in accordance with theinvention where there is a space to be filled along the length of thefastener, and whether the fastener is attached to body tissue or anotherimplant.

FIGS. 49 and 50 illustrate distal fastening to secure a femoralarthroplasty prosthesis 920A, provided with a non-smooth surface 926,for example a surface that is roughened or porous, or has at least onecavity therein. A fastener 1256, or other fastener of the invention, forexample fastener 1232 of FIG. 46D or 1240 of FIG. 46G, may be attachedusing distal vibratory fastening as described herein. Softened or meltedmaterial of the fastener enters into surface 926, and upon cooling, isfirmly attached due to the greater surface area for adhesion presentedby the irregularity of surface 926, or by an interlocking of the cooledand now hardened material into the shaped or roughened projections orcavities of surface 926. Distal fastening in accordance with theinvention may be carried out upon a smooth surface, however a non-smoothsurface offers the advantages described, including greater surface area,and an increased potential for mechanical interlocking. A combination ofknown methods, such as posts 1260, affixed by bone cement, and fastenersof the invention, may be combined as determined by the practitioner tobe optimal.

With reference to FIGS. 51 and 51A-B, a fastener 1600 has a plurality oftines 1610. While two tines are illustrated, it should be understoodthat any number of tines or projections may be employed in accordancewith the invention. Fastener 1600 is contacted by an end effector 104,or may be attached to an end effector of the invention, for example asdescribed for fastener 1250 shown if FIG. 46H, and vibratory energy isapplied to produce a bond between tines 1610 and a surface 1612.Vibratory energy is tuned as described herein, to produce heat proximatethe end of tines 1610 and surface 1612, whereby bondable material ofeither or both of tines 1610 and surface 1612 becomes softened orliquefied, whereupon a bond is formed between tines 1610 and surface1612.

Surface 1612 may be body tissue or another implant, and isadvantageously non-smooth, as described for example with respect tosurface 926 of FIG. 50. Where surface 926 is body tissue, it may beroughened or otherwise provided with a non-smooth surface, as by filing,drilling, or other known means, prior to bonding.

FIG. 51A illustrates a cross section of fastener 1600, showing anaperture through which an end effector may be attached, and or throughwhich body tissue or an additional implant may be affixed. As can beseen in FIG. 51B, a tine 1610 may be provided with one or moreprojections 1616 which may serve to maintain a location of fastener 1600prior to bonding, and which may promote bonding by becoming heated andsoftened earlier than the remainder of the tine, thus speeding theheating of tines 1610 for rapid and reliable bonding.

Referring now to FIGS. 53 and 53A, distal fastening is illustrated inthe context of an acetabular replacement implant 1800. A retrogradeapproach, as through illium 1806, is used to introduce a fastener of theinvention. Fasteners 1240 and 1250 are illustrated, although otherfasteners of the invention may be used. For fastener 1250, fastening isinto a shaped cavity 1802, formed in the retrograde side of implant1800. End effector 104, connected to fastener 1250, causes vibration atdistal end 1256 while applying force in the direction indicated by arrow“A”. The force urges distal end 1256 into shaped cavity 1802, generatingheat sufficient to soften distal end 1256, whereby it is urged intocavity 1802, enlarging and spreading to at least partially fill cavity1802, producing a partial shortening or collapse of the length offastener 1250, and forming a mechanical interlock between fastener 1250and implant 1800. After vibratory energy is discontinued, the materialof distal end 1256 cools and solidifies, and end effector 104 isremoved. Fastener 1250 thus prevents rotational movement of implant1800, though engagement with a bore or aperture 1804 through whichfastener 1250 passes. If aperture 1804 is tight fitting, fastener 1250may provide additional stability with respect to a movement of implant1800 away from contact with acetabulum 1808. A cap 1010 may additionallybe bonded using vibratory energy, as described herein, to providefurther.

With further reference to FIGS. 53 and 53A, fastener 1240 is introducedthrough a more antegrade approach than that of fastener 1250, but couldbe introduced through a retrograde approach as well. Rather than enterinto a relatively large cavity as shown for fastener 1250, fastener 1240bonds to a roughened or porous surface 1810, formed on the bodycontacting side of implant 1800, and is bonded therewith in a manner asdescribed herein. It should be understood that while fasteners 1250 and1240 are depicted for fastening into a cavity, and onto a poroussurface, respectively, the relative roles of the fasteners could bereversed, and other fasteners of the invention could be used asdescribed for either fastener 1240 or 1250.

It can be seen, as illustrated for fasteners 1250 and 1240 in FIGS. 53and 53A, that in the case of distal fastening, as well as proximalfastening, the fastener body can be advantageously caused to enlarge.The enlarged portion may prevent staked material from separating fromthe fastener, and can prevent the fastener from detaching from a bondedlocation. Further, the enlarged portion may be too large to pass throughthe portal or opening through which the fastener entered. As examples,distal end 1256 cannot be withdrawn from cavity 1802 after cooling, andcap 1010, formed onto fastener 1240 by proximal vibratory fastening,prevents passage of fastener 1240 inwardly towards acetabulum 1808.

The fasteners and fastening methods of the invention are advantageouslyutilized for use in-vivo, reducing or avoiding tissue necrosis byminimizing exposure of tissue to heat, and may be implemented throughreduced size incisions, including keyhole incisions, as may be employedin laparoscopic procedures. Fasteners may additionally be formed andfastened in accordance with the invention in the operating room, at theconvenience of the surgical practitioner, when the exact configurationand dimensions needed are best understood, and thereafter implanted.

Spinal Fixation

With reference to FIGS. 55-57, fastening in accordance with theinvention can be advantageously applied to correction of problems of thespine 2000. In FIG. 55, a vertebra 2002 is shown, the vertebral body2004 containing a bondable material 1206, placed using, for example,vertebroplasty or kyphoplasty. A spinal fastener 2008 has been driveninto vertebral body 2004, and embedded within bondable material 1206using vibratory energy.

With reference to FIGS. 28A-C, an angulated screw 2016 can be placed atan angle through a plate 2018, 2018A and then driven or staked in place.Screws 2016 and plates 2018, 2018A have a rounded mating surface 2020,2022 respectively, which allows some adjustability in direction of screw2016 relative to plate 2018, 2018A. Screw 2016 can be inserted, forexample, 11 degrees off of a straight line axis through mounting holes2024 through which they project.

With reference to FIG. 29, in accordance with one embodiment of theinvention, in order to stake screw 2016, an end effector 2026 having achange in diameter 2028 can be used. An enlarged mating surface 2028 issized to engage screw 2016 regardless of its angle within mating surface2022. FIG. 28B shows a single hole plate 2018 with the rounded hole, andFIG. 28C shows a four hole plate 2018A with angulated screws prior tostaking. In this embodiment, surface 2022 and or a portion of matingsurface 2020 of fastener 2016 contains bondable material, wherebyapplication of end effector 2026 can apply vibratory energy sufficientto bond surfaces 2020 and 2022, regardless of the angle of fastener2016. In addition or alternatively, bondable material may be provided ata distal end 2030 of fastener 2016, and vibratory energy may be appliedto bond distal end 2030 as described herein for distal fastening.

Spinal fastener 2008 may be provided with a distal end 2010 that isseparable, or is otherwise shaped as described for fastener 800;however, any of the other end forms or fasteners described herein may beselected in the discretion of the practitioner. As described for examplewith respect to FIG. 28, spinal fastener 2008 may be provided with ahead portion having a profile 2020 shaped to engage a mating support2024, whereby spinal fastener 2008 may be secured at an angle relativeto support 2018, 2018A. In this manner, a fracture may be stabilized,successive vertebrae may be maintained in a fixed relation relative toeach other, or a secure fixation point may be established. In FIG. 55,two spinal fasteners 2008 are secured together by clamps 2012, which mayhave the form described with respect to FIGS. 27A-C. A rod 2014 issecured between clamps 2012. Alternatively, rod 2014 may be connectedbetween clamps 2012 on different vertebrae, according to the needs ofthe patient.

As may further be seen in FIG. 55, a mesh pouch or bag 2016 contains atherapeutic substance, and is placed proximate a surgical site or areaneeding treatment over time. Bag 2016 may contain any of the therapeuticsubstances described herein or in the incorporated references, or otherbeneficial agent as known in the art, including for exampleantimicrobial agents, or bone healing or ingrowth agents. Formed with amesh, bag 2016 enables the inward migration of gaseous or liquidmaterials from the body, or body tissue ingrowth, and the outwardmigration of therapeutic substances. Bag 2016 may be attached to animplanted structure, such as fastener 2008, clamp 2012, or rod 2014, byattachment means, for example by one or more sutures (not shown). Bag2016 or attachment means may be biodegradable or bioabsorbable.

With reference to FIG. 56, in a further embodiment, a connector 2032 isfastened to heat melatable material 1206 within vertebral body 2004,using fasteners 2034. Connector 2032 is shown as an elongated bar,strip, or strap that extends between vertebrae. Fasteners 2034 may besecured to bone, or to bondable material 1206, as shown in cross sectionfor vertebra 2036. Any of the fasteners or methods of the invention maybe used to attach connector 2032 to vertebrae. Connector 2032 may beused to secure vertebrae with respect to each other, or to secure avertebral component to any other object within the body, including otherbones, soft tissue, or implant, or to a point external to the body, suchas a brace or other external fixation device. Fastener 2034 may beselected from any of the fasteners described herein, depending upon, atleast, the fixation medium, and the needs of the patient.

An alternative view may be found in FIG. 74B, wherein a plate 2046 isprovided, for additional strength, if needed, and to provide forstabilization with movement permitted along a limited range of motion.In particular, plate 2046 is limited in movement relative to astabilizing fastener 2050. Elongated slot 2048 enables vertical oranteroposterior motion of plate 2046 relative to fastener 2050, howeverfastener 2050 is secured within the disc space, and thus the disc spacecannot move dorsoventrally. Elongated slot 2048 may be formed alongother angles, and plate may be positioned in other locations, enablinglimited range of motion along other axes, as would be understood by oneskilled in the art.

Referring now to FIG. 57, one or more fasteners 2038 in accordance withthe invention are embedded within bondable material 1206, disposedwithin a space associated with a vertebra, in this embodiment, thevertebral body 2004. fasteners 2038 may alternatively be fastened tobondable material disposed on the outside surface of the vertebra, ribs,or other bone of the body. In the embodiment shown, a strap 2040 passesfrom one fastener 2038 to another, and is bound to each, as by anaperture through which a portion of each fastener 2038 passes.Alternatively, strap 2040 and or fastener 2038 may include bondablematerial, and the elements are bonded together using vibratory energy asdescribed herein. While two fasteners 2038 are shown, it should beunderstood that additional fasteners 2038 could be used, or a singlefastener 2038, wherein strap 2040 passes completely around an object tofasten to fastener 2038 at more than one point along its length. Tofurther secure strap 2040 to one or more fasteners 2038, heads or caps1010 may be attached to fasteners 2038 as described herein, oralternatively, to strap 2040. If attachment is to strap 2040, either orboth of caps 1010 or strap 2040 is fabricated with heat softenablematerial, and the elements are bonded using vibratory energy asdescribed herein. In the partial cross section shown in FIG. 57, afracture 2042 is illustrated, maintained in a position for healing byfasteners 2038 and strap 2040.

Locking Screw Fastening

In another embodiment of the invention, a metallic polyaxial screw/rodsystem, of the type typically used in spinal surgery, is modified toinclude holes intersecting both the saddle that holds the rod andpedicle screw head, and the locking screw used to maintain the desiredangle of the pedicle screw. Into these holes, a tack is staked or bondedsuch that the material of the tack flows into the threads between thesaddle and locking screw, effectively preventing loosening of thesystem.

Resecuring or Removing an Implant

As described above, vibratory energy, such as ultrasonic energy, is usedto melt or liquify adhesives, including bone cement. In accordance withthe invention, and with reference to FIGS. 46 and 46A, bone cement ismelted in situ, whereupon melted cement softens or flows to bridge orcross and fill or close voids and gaps 1208 between the implant and bodytissue, the cement thereafter being allowed to cool in order to thusre-secure or reduce the loosening of the implant.

With reference to FIGS. 46-47, assembly 1202 including end effector 104,is passed into a space within the body, in the example shown,intramedullary canal 1222 within bone 882. End effector 104 is providedwith at least one shaped projection 1200. Projections 1200 may bethreadably or otherwise mechanically connected to end effector 104,whereby the projections 1200 may be left inside the body for, asexamples, future use, convenience, or further stabilization. Projections1200 may have any convenient shape, and advantageously has a tip and atleast one side edge which has a tapered profile, to facilitate passagethrough bondable material 1206.

To facilitate passage of end effector 104 and at least one projection1200, a bore 1204 may be preformed within cancellous bone or tissue ofintramedullary canal 1222. For other body areas, space may be made asneeded, for example by retraction, insufflation, or other means known inthe art. In another alternative, end effector 104 is formed as a hollowtube, as in a coring drill, to facilitate passage through body tissue.

In an alternative embodiment, projections 1200 may be formed as acontinuous or substantially continuous surface, thus forming the shapeof a cone, cylinder, box or shaped space, as may be seen for example inFIGS. 46D-46F. If bore 1204 is narrower than the width of projections1200, the latter may be formed of sufficiently flexible material as tocollapse while within the bore, and expand upon reaching an area ofbondable material 1206.

Upon reaching bondable material, vibratory energy is generated withinprojections 1200, through a connection with end effector 104 attached togenerator and handpiece 908, as described herein. In this manner,bondable material 1206 is made flowable by the application of vibratoryenergy through contact with projections 1200. Projections 1200 may thenbe pushed further into bondable material 1206 to a desired depth. In theexample shown, projections 1200 are deflected by implant 880 and enterthe interstice between body tissue and implant 880, filled with bondablematerial 1206. As bondable material 1206 is melted, voids or gaps, suchas gap 1208, formed by a loosening of implant, may be filled, and uponcooling, the implant is restabilized. It should be understood that gap1208 is shown above projection 1200, for clarity; however, projections1200 are provided with a length sufficient to reach a gap of concern.

Once bondable material has been sufficiently softened, end effector 104may be rotated to correct further defects along the path of movingprojections 1200. After gaps 1208 have been corrected, end effector 104and or projections 1200 may then be withdrawn, or alternatively, eitheror both devices may be left within the body. If end effector 104 is tobe removed, it is first decoupled from projections 1200, for example atreleasable coupling 1210.

In an alternative embodiment, a fastener 1270 or end effector 104A ispassed to gap 1208 from a side entry. Fastener 1270 may be of the typeshown, for example, in FIGS. 46D-H, or may be modified with an endportion 1272 having a more blunt profile, thereby increasing a contactsurface. End effector 104A may similarly be provided with a widened orblunt profile 1274. Fastener 1270 or end effector 104A is caused tocontact bondable material 1206 at a gapped portion 1208, either bydrilling a hole to access gap 1208, or by driving or drilling fastener1270 or end effector 104A to gap 1208. Vibratory energy may further beemployed, particularly if passing through bondable material 1206 toreach gap 1208. Upon reaching gap 1208, vibratory energy is applied toremelt bondable material 1206 to cause same to soften and flow to crossand fill in gap 1208. In this manner, fastener 1270 is acting as avibratory horn, transmitting vibratory energy from a vibratory energygenerator to bondable material 1206 proximate gap 1208. In FIG. 46A, agap 1208 is shown to extent from a point indicated at “A” to a pointindicated at “B”. As can be seen, regions of gap 1208 have been closedby the introduction of fastener 1270 and end effector 104A. It should beunderstood that, depending upon the length and width of gap 1208, that aportion or the entire gap 1208 may be remelted and corrected, dependingupon the size of end portion 1272 or profile 1274, and the amount andduration of vibratory energy applied. Melting may further be caused tooccur along a side portion of fastener 1270 or end effector 104A.

In addition to remelting existing implant binding material or bondablematerial 1206, additional material may be introduced that is associatedwith fastener 1270. Specifically, fastener 1270 may be fabricated frombondable material 1206, or a different bondable material, which iscaused to additionally soften upon the application of vibratory energy,and to flow into and further fill gap 1208. Alternatively, fastener 1270may be provided with bondable material at least in an area upon fastener1270 which is intended to form a contact proximate gap 1208.

It may further be seen that, in the example shown, end effector 104A isangled in a first direction, and fastener 1272 in a contrary direction.The surgical practitioner may select an angle with respect to a vectorin a direction of insertion of the implant, that best causes remelting,and that provides further stability if end effector 104A or fastener1272 is left in the body. It may be advantageous to affix the vibratoryhorn, here further serving as an implanted fastener, at an obtuse angle,as measured between a line extending along the longitudinal axis of thevibratory horn, and a line extending from a point where the vibratoryhorn contacts the binding material 1206, extending in a direction ofinsertion of the implant, as may be seen for fastener 1270.

End effector 104A or fastener 1274 may be trimmed at a convenient point,for example at the surface of bone 822. Alternatively, as illustrated bydotted lines 1276, end effector 104A or fastener 1274 may extend to amore distant point, for example to the surface of the skin, or toexternal fixation apparatus.

With reference to FIGS. 46B-D, projections 1212 are at least partiallycoated with a bondable material 1214. Where the bondable material lackssufficient strength for an intended application, one or more ofprojections 1200 may be included, underlying bondable material 1214. Inthis embodiment, projections 1212 may enter the body as described withrespect to FIGS. 46 and 46A, and in particular, projections 1212 may besqueezed together, to resiliently expand after passing through apassageway. Assembly 1220 may be used to soften bondable material 1206,particularly where bondable material 1206 has the same or a lowermelting point than bondable material 1204. In this manner, assembly 1220illustrated in FIGS. 46B-D may be used in a manner similar to thatdescribed for assembly 1202 of FIGS. 46 and 46A. However, becauseassembly 1220 incorporates bondable material 1214, it may be used inapplication where there is little or no other bondable materialavailable at a target location.

FIG. 46C illustrates assembly 1220 inserted within the body, afterhaving been softened by the application of vibratory energy. As can beseen in the illustration, bondable material 1214 near a proximal area1224 has flowed upwards to a distal area 1226. Bondable material 1206,if existing, is mixed with, or displaced by, bondable material 1214.After cooling, projections 1212 are affixed to bone 882, implant 880, orboth. In this embodiment, although a connector 1210 may be provided, itis particularly advantageous to have end effector 104 connected, wherebyit may be used to not only secure an additional implant, such asarthroplasty component 920 as illustrated in FIG. 43, but may serve tosimply anchor implant 880, as illustrated in FIG. 42.

With reference to FIG. 46D, in one embodiment, an assembly 1232 includesa vibratory end effector 104 provided with a heat meltable connector1230 having either an amorphous or defined shape, including a hollowspace, for example a blob 1234, wedge, cone 1236 or tube 1238, as bestadapted to the application. Connector 1230 is advantageously used whereit is not necessary to resecure or separate a large region of bondablematerial 1206, but rather, to connect a first implant and a secondimplant, or a first implant to body tissue, for example to cartilage,tendon, bone, or soft tissue.

If it is desired to re-secure the implant, the blade may be withdrawnonce the implant has been repositioned, if desired, and the void or gapof concern has been re-filled with melted adhesive. Alternatively, if itis desired to remove the implant, removal is accomplished before theadhesive resolidifies, such as by lifting the implant away from theadhesive, out of its current location. Multiple blades may be employedto reduce the time required to complete the removal or resecuringprocess.

Alternative shaped projections include cups, cones, wires, or othershapes which may pass through the body to the area where the adhesive islocated, and which are advantageously formed to best fit the geometry ofthe adhered interface, to carry out the functions previously described.

In an alternative embodiment, the rod and blades are left within thebody, embedded in the resolidified cement, to operate as a reinforcementand or attachment point for further fasteners or implants, includingarthroplasty components and prosthetics, or testing or reportingapparatus attached to or embedded within the device. As an attachmentpoint, the rod may be provided with bores or apertures, which may bethreaded, into which other fasteners may be inserted, and optionallyfurther fastened in accordance with the methods disclosed herein.

In an alternative embodiment, the shaped projection is formed of, orcoated with, a bondable material, for example a polymer, which is thenbonded to a roughened or porous surface, either in the operating room,or in the body. Within the body, the surface may be that of existing orimplanted bone, or that of a previously or recently positioned implant.When the shaped surface is positioned in contact with the roughenedsurface, for example an intramedullary rod having a porous metalsurface, vibratory energy is passed to the shaped projection to causethe projection to melt and bond to the roughened surface.

The issue of implant removal after bonding or staking of one or moreimplants is one that needs to be addressed as the clinical situationdictates.

With regard to FIGS. 46, and 46A-46D, it can be seen that while thebondable material is liquified or softened by vibratory energy, removalof an adhered object is facilitated. This is particularly useful forwell fixed implants, and particularly objects within the intramedullarycanal.

Referring now to FIGS. 15-18, end effector 250 is shown, which usesvibratory energy as part of an implant removal tool 252. Implant removaltool 252 includes hollow end effector 252 and a T handle 254. Theproximal end of end effector 250 has an internal thread 256 that matchesthe threading on the hand piece of a vibratory generator. The proximalend also has an external thread 258 that matches the threading on Thandle 254. T handle 254 can also be provided with a pin or otherprojection that extends into end effector 250 for increasing stability.Although the proximal end is shown and described as having threads 256and 258 to mate with the hand piece and T handle, respectively, anysuitable mechanism for removably connecting the end effector to the handpiece and T handle can be used. Additionally, the mechanisms forconnecting to the hand piece and T handle could be reversed with theexternal surface used for the hand piece and the internal surface usedfor the end effector.

The distal end of end effector 250 is provided with surface asperities260 or otherwise roughened to help grip the implant or material to beremoved. In use (FIG. 17), end effector 250 is connected to a vibratoryhand piece and is placed over an implant 262 to be removed. Head 264 canbe removed (using vibratory energy or by simply shearing off) fromimplant 262 to help ensure end effector 250 is centered over implant262. The vibratory energy is activated to drive end effector 250 aroundimplant 262 and into the rod 266 to which implant 262 is bonded. Instudies conducted to date, an energy level of 80 to 100 Watts with notime limit is sufficient. Average insertion time is around 2-5 seconds.Upon cooling of the material of implant 262, the material of implant 262adheres to end effector 250.

Leaving end effector 250 around implant 262, the hand piece is removedfrom end effector 250 and T handle 254 is connected. Repeated rocking oroscillating motion on T handle 254 is used to break the bond or weldsuch that when T handle 254 is pulled back, implant 262 is removed.

The present invention also contemplates the use of end effector 250 forremoving screws and other implants from bone. End effector 250 could bedisposable (single use) such that removal of the cored implant would notbe necessary. Alternatively, end effector 250 could be reusable.

Fastening Dissimilar Materials

It should be understood that a proximal or distal polymer to polymerconnection may be made through the application of energy, such asvibratory energy, as described herein. In this manner, fastenercontaining polymer may be connected to a roughened, porous or shapedsurface, or to another polymeric fastener, or polymeric coating on animplant or implanted fastener. For example, an arthroplasty orprosthetic component may be at least partly covered with polymer, thepolymeric surface exposed to an intended site for fastening. Moreover, aplurality of arthroplasty components may include polymeric or heatsoftenable material, the components being thus fastenable together inaccordance with the invention.

An advantage to a polymeric containing, or polymeric coated fastener orimplant is the ability to incorporate one or more therapeutic substanceswithin the coating, whereupon the therapeutic substance may elute, orrelease the therapeutic substance in-vivo over time, in a predictableand useful manner. U.S. Provisional Patent Application No. 60/728,206,entitled “Drug Eluting Implant” and incorporated herein by reference,provides examples of means for delivering therapeutic agents, althoughthose skilled in the art will appreciate that other known methods may beadvantageously employed in combination with the invention.

Fastening Combinations and Applications

It is contemplated the surgical system of the present invention may beused with and integrated with the methods and devices disclosed in U.S.Provisional Application No. 60/765,857 entitled “Surgical FasteningDevice” filed on Feb. 7, 2006. In the '857 document, variousthermoplastic fastening devices are disclosed. The fastening devices maybe, but are not limited to, degradable, biodegradable, bioerodible,bioabsorbable, mechanically expandable, hydrophilic, bendable,deformable, malleable, riveting, threaded, toggling, barded, bubbled,laminated, coated, blocking, pneumatic, one-piece, multi-component,solid, hollow, polygon-shaped, pointed, self-introducing, andcombinations thereof. Also, the devices may include, but are not limitedto, metallic material, polymeric material, ceramic material, compositematerial, body tissue, synthetic tissue, hydrophilic material,expandable material, compressible material, bondable material, andcombinations thereof.

The methods and devices disclosed in the '857 document may be used inconjunction with any surgical procedure of the body. The fastening andrepair of tissue or an implant may be performed in connection withsurgery of a joint, bone, muscle, ligament, tendon, cartilage, capsule,organ, skin, nerve, vessel, or other body parts. For example, tissue maybe repaired during intervertebral disc surgery, knee surgery, hipsurgery, organ transplant surgery, bariatric surgery, spinal surgery,anterior cruciate ligament (ACL) surgery, tendon-ligament surgery,rotator cuff surgery, capsule repair surgery, fractured bone surgery,pelvic fracture surgery, avulsion fragment surgery, shoulder surgery,hernia repair surgery, and surgery of an intrasubstance ligament tear,annulus fibrosis, fascia lata, flexor tendons, etc.

It is contemplated that the devices and methods of the present inventionbe applied using minimally invasive incisions and techniques to fastenmuscles, tendons, ligaments, bones, nerves, and blood vessels. A smallincision(s) may be made adjacent the damaged tissue area to be repaired,and a tube, delivery catheter, sheath, cannula, or expandable cannulamay be used to perform the methods of the present invention. U.S. Pat.No. 5,320,611 entitled “Expandable Cannula Having Longitudinal Wire andMethod of Use” discloses cannulas for surgical and medical useexpandable along their entire lengths. The cannulas are inserted throughtissue when in an unexpanded condition and with a small diameter. Thecannulas are then expanded radially outwardly to give a full-sizeinstrument passage. Expansion of the cannulas occurs against theviscoelastic resistance of the surrounding tissue. The expandablecannulas do not require a full depth incision, or at most require only aneedle-size entrance opening.

U.S. Pat. Nos. 5,674,240; 5,961,499; and 6,338,730 also disclosecannulas for surgical and medical use expandable along their lengths.The cannula can be provided with a pointed end portion and can includewires having cores which are enclosed by jackets. The jackets areintegrally formed as one piece with a sheath of the cannula. The cannulamay be expanded by inserting members or by fluid pressure. An expandablechamber may be provided at the distal end of the cannula. The abovementioned patents are hereby incorporated by reference.

In addition to using a cannula with the present invention, an introducermay be utilized to position implants at a specific location within thebody. U.S. Pat. No. 5,948,002 entitled “Apparatus and Method for Use inPositioning a Suture Anchor” discloses devices for controlling theplacement depth of a fastener. Also, U.S. patent application Ser. No.10/102,413 discloses methods of securing body tissue with a roboticmechanism. The above-mentioned patent and application are herebyincorporated by reference. Another introducer or cannula which may beused with the present invention is the VersaStep® System by Tyco®Healthcare.

The present invention may also be utilized with minimally invasivesurgery techniques disclosed in U.S. patent application Ser. No.10/191,751 and U.S. Pat. Nos. 6,702,821 and 6,770,078. These patentdocuments disclose, inter alia, apparatus and methods for minimallyinvasive joint replacement. The femoral, tibial, and/or patellarcomponents of a knee replacement may be fastened or locked to each otherand to adjacent tissue using fastening devices disclosed herein andincorporated by reference. Furthermore, the methods and devices of thepresent invention may be utilized for repairing, reconstructing,augmenting, and securing tissue or implants during and “on the way out”of a knee replacement procedure. For example, the anterior cruciateligament and other ligaments may be repaired or reconstructed;quadriceps mechanisms and other muscles may be repaired; a damagedrotator cuff may be mended. The patent documents mentioned above arehereby incorporated by reference.

Furthermore, it is contemplated that the present invention may be usedwith bariatric surgery, colorectal surgery, plastic surgery,gastroesophageal reflex disease (GERD) surgery, or for repairinghernias. A band, mesh, or cage of synthetic material or body tissue maybe placed around an intestine or other tubular body member. The band mayseal the intestine. This method may be performed over a balloon orbladder so that anastomosis is maintained. The inner diameter of thetubular body part is maintained by the balloon. The outer diameter ofthe body part is then closed or wrapped with a band, mesh, or patch. Theinner diameter of the tubular body member may be narrowed or restrictedby the band. The band may be secured to the tubular body part orsurrounding tissue with the devices and methods described herein andincorporated by reference.

It is further contemplated that the present invention may be used inconjunction with the devices and methods disclosed in U.S. Pat. No.5,329,846 entitled “Tissue Press and System” and U.S. Pat. No. 5,269,785entitled “Apparatus and Method for Tissue Removal.” For example, animplant secured within the body using the present invention may includetissue harvested, configured, and implanted as described in the patents.The above-mentioned patents are hereby incorporated by reference.

Additionally, it is contemplated that the devices and methods of thepresent invention may be used with bondable materials as disclosed inU.S. Pat. No. 5,593,425 entitled “Surgical Devices Assembled Usingbondable materials.” For example, the implants of the present inventionmay include bondable material. The material may be deformed to securetissue or hold a suture or cable. The fasteners made of bondablematerial may be mechanically crimped, plastically crimped, or may bebonded to a suture or cable with RF (Bovie devices), laser, ultrasound,electromagnet, ultraviolet, infrared, electro-shockwave, or other knownenergy. The bonding may be performed in an aqueous, dry, or moistenvironment. The bonding device may be disposable, sterilizable,single-use, and/or battery-operated. The above-mentioned patent ishereby incorporated by reference.

Furthermore, the methods of the present invention may be performed underindirect visualization, such as endoscopic guidance, computer assistednavigation, magnetic resonance imaging, CT scan, ultrasound,fluoroscopy, X-ray, or other suitable visualization technique. Theimplants, fasteners, fastener assemblies, and sutures of the presentinvention may include a radiopaque material for enhancing indirectvisualization. The use of these visualization means along with minimallyinvasive surgery techniques permits physicians to accurately and rapidlyrepair, reconstruct, augment, and secure tissue or an implant within thebody. U.S. Pat. Nos. 5,329,924; 5,349,956; and 5,542,423 discloseapparatus and methods for use in medical imaging. Also, the presentinvention may be performed using robotics, such as haptic arms orsimilar apparatus. The above-mentioned patents are hereby incorporatedby reference.

Moreover, the devices and methods of the present invention may be usedfor the repair and reconstruction of a tubular pathway like a bloodvessel, intestine, urinary tract, esophagus, or other similar bodyparts. For example, a blood vessel may be intentionally severed during asurgical operation, or the blood vessel may be damaged or torn as aresult of an injury. Flexible fastening of the vessel would permit thevessel to function properly and also compress and stabilize the vesselfor enhanced healing. To facilitate the repair or reconstruction of abody lumen, a balloon may be inserted into the lumen and expanded so thedamaged, severed, or torn portion of the vessel is positioned againstthe outer surface of the inflated balloon. In this configuration, theimplants and methods described and incorporated herein may be used toapproximate the damaged portion of the vessel.

It should further be understood that vibratory energy, and particularlyultrasonic energy, may be created within the body, through a barriersuch as skin or other body tissue. This is described more particularlyin pending U.S. application Ser. No. 10/945,331 (Publication2006/0064082), of common inventor P. Bonutti, the contents of which arehereby incorporated herein by reference.

Focal Defect Correction

With reference to FIGS. 96-96B, in accordance with the invention, areasof disease or trauma representing a focused or focal defect 3800 arereplaced with an implant or graft 3802, secured in situ using vibratoryenergy. In this manner, healthy tissue 3804 may remain undisturbed, anddefect 3800 is corrected. Examples include replacing a portion of anarticulating surface, such as a condyle 3806, acetabulum, or glenoidfossa, or replacing portions of bone or soft tissue that have beendamaged by injury or disease.

The diseased area is replaced by, for example, implanted tissue,including bone fragments or compressed living tissue, fabricatednon-living material such as polymers or metal, or any other material amedical practitioner deems best. An interface 3808 is created betweengraft 3802 and body tissue 3804, and includes a quantity of bondablematerial 3810 therebetween. Advantageously, if the implant is not madeentirely from bondable material, a surface 3812 of the implantcontacting the bondable material of the interface is provided with aroughened or porous surface, or a surface with one or more cavities intoor onto which heat softened or melted material may flow and thereby lockonto once cooled, hereafter an irregular surface. Similarly, the bodytissue 3804 may be treated to have an irregular surface 3814 for purposeof improving a bond between body tissue 3804 and bondable material 3810.In addition, an implant 3816 may be attached to body tissue 3804 usingmethods or devices of the invention, or alternatively screws 3818,adhesives, or any other known means, and the implant may be providedwith an irregular surface 3820 for the purpose of improving a bondbetween implant 3816 and bondable material 3810.

Thus, once graft 3802 is in place, interface 3808 defines a strata thatincludes body tissue 3804 having an irregular surface 3814, or animplant 3816 attached to body tissue 3804, implant 3816 having anirregular surface 3820, bondable material 3810, and graft 3802 having anirregular surface 3812, unless the implant is provided with bondablematerial at interface 3808. If a bond of satisfactory strength may bemade without irregular surface at 3812, 3814 or 3820, the irregularsurface need not be formed or provided.

Vibratory energy is applied proximate the interface by an end effector104, and horn 3822, operative to cause bondable material 3810 withininterface 3808 and within graft 3802, if present, to soften or melt,thereby locking onto the irregular surface of both body tissue 3804 orintervening implant 3816, if present, and graft 3802, whereby graft 3802is firmly attached to the body once bondable material 3810 has cooled.Horn 3822 is advantageously provided with a shape which improvestransfer of vibratory energy either directly to interface 3808, or tograft 3802, which may be caused to vibrate to heat interface 3808.

bondable material 3810 may be provided in the form of a wedge 3810A,which may be driven into a gap between graft 3802 and body tissue 3804,whereby a tight and secure connection is formed, operative to maintaingraft 3802 in a desired position during bonding, and to improve thetransfer of vibratory energy throughout interface 3808.

Chain of Fastening

The invention specifically contemplates a chain of fastening from boneto implant to tissue. For example, bone cement is fastened to bone, animplant is fastened to the bone cement as described herein, tissue isstaked or fastened to the implant, and the end of the implant is cappedor secured as described herein and in the incorporated references.Fasteners may alternatively be bonded to bone using methods describedand illustrated herein and described in the incorporated references, andimplants or tissue are fastened to the fastener bonded to bone, usingthe methods and devices of the invention.

Examples of chains of fastening have been provided elsewhere herein, andFIG. 91 illustrates a further example. Specifically, a mesh 3400 isfastened within the body by one or more fasteners 3502 in accordancewith the invention. In the example of FIG. 91, fastener 3502 is selectedfrom fasteners of the invention which enable the formation of cap 1010.Further, an embedded fastener 800 (not shown) may be used to securefastener 3502 within body tissue 3504. In the example illustrated, mesh3502 is operative to promote the growth of cells, shown symbolically ascircles 3506, and may also be used to close, bridge or secure a fissureor tissue gap 3508 from further expansion, until tissue growth closestissue gap 3508. Mesh 3500 may incorporate therapeutic substances asdescribed elsewhere herein, in any of the manners described elsewhereherein. For example, mesh 3500 may be coated with a bondable materialincorporating a tissue ingrowth agent. The aperture size of mesh 3500may be selected to promote the type of tissue ingrowth desired; forexample, bone ingrowth is favored by an aperture size of 100-400microns, whereas soft tissue growth is favored by an aperture size of50-150 microns.

Mesh 3500 is advantageously coated with, or fabricated from, a bondablematerial. As such, as caps 1010 are formed as described elsewhereherein, caps and associated fasteners 3502 are additionally fastened tobondable material of mesh 3500 by vibratory fastening in accordance withthe invention. Accordingly, mesh 3500 is secured to body tissue 3504with greater strength and reliability.

The invention further contemplates connecting implants together usingvibratory energy. Examples have been given elsewhere herein, andadditional examples are provided in FIGS. 92-93A. Specifically, withreference to FIG. 92, a first stent 3500 is disposed within a a tubularbody vessel 3502, for example a blood vessel, within a patient, and asecond stent 3504 is positioned within a branching blood vessel 3506. Aconnecting fastener 3508 in accordance with the invention is positionedbetween stent 3500 and stent 3504, and is connected to both stents 3500,3504, at regions 3510, 3512, respectively. Connecting fastener 3508includes a bondable material at least upon its surface, and may befabricated entirely of a bondable material.

When connecting fastener 3508 is positioned in overlapping contact withstent 3500, vibratory energy may be applied along a portion or theentire overlapping region of connecting fastener 3506, in order to causebondable material of connecting fastener to soften and form aroundmaterial of stent 3500 and 3504, wherein upon cooling, connectingfastener is firmly attached to stent 3500 and 3504.

In accordance with the invention, vibratory energy may be providedinside blood vessel 3502 or 3506, or other confined space, by an endeffector 104 disposed at the end of a catheter or laparoscopic shaft3514. Vibratory energy is generated at piezo stack 3516, supplied with asuitable signal through wires (not shown) extending within shaft 3516.Visualization may be carried out using fluoroscopy or other knownmethod. Alternatively, connecting fastener 3508 is fabricated withmetal, and is caused to vibrate to produce heat using a source ofultrasonic vibration produced outside the body and directed atconnecting fastener 3508, to cause the latter to vibrate resonantly, asdescribed for example in copending U.S. patent application Ser. No.10/945,331, the contents of which are incorporated herein by reference.

Stent 3500 and or 3504 (hereafter referred to as stent 3500) may befabricated partially or entirely with bondable material. In this manner,vibratory energy applied at a region of overlap between stent 3500 andconnecting fastener 3508 may operate to cause melting of bondablematerial of connecting fastener 3508 and stent 3500, whereby bonding ispotentially improved by integration of bondable material of bothconnecting fastener 3508 and stent 3500. Alternatively, or in additionto connecting fastener 3508 containing metal, stent 3500 may befabricated with metal and caused to vibrate and produce heat sufficientfor softening bondable material of stent 3500, or bonding with bondablematerial of connecting fastener 3508.

Additionally, vibratory energy may be applied to stent 3500 to softensame, facilitating expansion. Stent 3500 is generally transferred to animplantation site in an unexpanded state, typically surrounding aballoon catheter, as known in the art. An unexpanded stent isillustrated, for example, in FIG. 93. A heated stent 3500 may be easierto expand, particularly if coated with bondable material, and moreparticularly if there are multiple layers of material, possiblyincluding therapeutic substances.

It should be understood that stent 3500 and connecting fastener may beformed of biodegradable material. It should further be understood thatother expandable devices, or alternatively filtration devices, or anyother such device adapted to reside within a space in the body may beadapted as described for stent 3500, and may be bonded within the body,operating room, or other setting, in accordance with the invention.

Referring now to FIG. 93-93A, stent 3500 and 3500B are bonded togetherwithin tubular body tissue 3502A at connection area 3520, shown at apossibly enlarged size for clarity, comprising bondable material ofeither stent 3500 or 3500B or both, melted by vibratory energy appliedas described above. In this embodiment, there is no requirement for aseparate connector, such as connecting fastener 3508.

With further reference to FIGS. 93-93A, a collapsed or non-expandedstent 3500A is positioned within the body using known means, positionedto be overlapped by another stent 3500 along a portion of its length.Stent 3500A is then expanded, possibly softened using vibratory energyas described above, whereby portions of stent 3500A contact portions ofstent 3500B. Bonding may then take place, representatively illustratedat 3522. In addition to extending a length of body tissue supported by astent, this embodiment enables a second stent 3500A to be securely fixedwith respect to a first stent 3500. Moreover, if tissue ingrowth hasoccurred within the first stent 3500, second stent 3500A may then beused to increase an occluded diameter of first stent 3500 by beingexpanded within first stent 3500.

An alternative approach is further illustrated in FIGS. 93-93A, whereinstent 3500C is bonded to a side surface of stent 3500B, the bondingillustrated at 3524, gaining access through tubular body tissue 3502B.Stent 3500C may abut stent 3500B, or alternatively, stent 3500 B may beprovided with an aperture into which stent 3500C is sized to fit. Ineither event, bonding is accomplished as described above.

With reference to FIG. 94, two tubular body tissue members 3604, 3608are joined in a surgical anastomosis procedure of the invention. Asupporting frame 3610 is provided to maintain segments 3604, 3608 in anopen, flowing configuration, should tubular body tissue 3604, 3608require additional support. Other methods of supporting tissue duringanastomosis are disclosed in U.S. Pat. No. 5,254,113 to Wilk, thecontents of which are incorporated herein by reference. One or morebands 3600 is positioned to encircle one or more segments 3604, 3608,overlapping supporting frame 3610. Band 3600 comprises bondable materialalong at least one end portion 3602 of an exterior surface. Wherebondable material is provided on only one end portion, a joining portion3602A is advantageously provided with a roughened or porous surface, ora surface having one or more cavities therein. Accordingly, vibratoryenergy may be applied to one or more end portions 3602, 3602A, to causebondable material thereof to soften or melt in accordance with theinvention. If both ends 3602, 3602A contain bondable material, therespective material will become bonded at 3616, and upon cooling, band3600 will be secured in place. If one end of 3602 or 3602A containsbondable material, bonding takes place between the ends by mechanicalinterlock, improved by the roughened surface of the other end. Band 3600advantageously comprises material which shrinks when warmed, wherebyheat imparted by application of vibratory energy causes ends 3602, 3602Ato not only bond together, but causes band 3600 to shrink in order toimprove a seal between band 3600, body tissue 3604, 3608, and supportingframe 3610.

With reference to FIG. 95, a band 3612 is provided, sufficiently wide tooverlap at least a portion of both body tissue 3604 and 3608. Band 3612is fastened, and optionally heat shrunk, as described for bands 3600. Ifsupporting frame 3610 is required to maintain body tissue 3604, 3608open and flowing, it is provided as described with respect to FIG. 94.

In a further embodiment of the invention, vibratory energy is applied toat least a portion 3614 of band 3612 which is in overlapping contactwith supporting frame 3610. In this manner, if contacting surfaces ofsupporting frame 3614 and band 3612 contain bondable material, they maybecome bonded, rendering the union of body tissue 3604 and 3608 moredurable, and potentially improving a seal between band 3612, body tissue3604, 3608, and supporting frame 3614.

It should be understood that while various methods of bonding areillustrated together in FIGS. 92-94, and throughout the specification,any or all methods may be combined as deemed best by the medicalpractitioner.

Referring now to FIGS. 78-80, methods of the invention may be combinedto construct prostheses or other implants. In FIG. 78, end effector 104and horn 800 of FIG. 32A apply vibratory energy to a threaded post 3920projecting from an upper base layer 3922. A supply of bondable material3924 is introduced proximate a point of heating caused by theapplication of vibratory energy, whereupon bondable material 3924 iscaused to melt and bond to post 3920 and upper layer 3922, operative tosecure post 3920 and layer 3922 relative to each other, as may be seenin FIG. 79.

With further reference to FIG. 79, a horn 3926, connected to an endeffector (not shown), is applied to upper layer 3922. Lower layer 3928contains bondable material, or alternatively, bondable material isplaced between layers 3922 and 3928. Upon application of vibratoryenergy through horn 3926, layers 3922 and 3928 are caused to vibraterelative to each other along at least an area underlying horn 3926,causing bondable material 3930 of layer 3928 to soften or melt and bondto the underside of layer 3922, as may be seen in FIG. 80. A variety ofpermutations are possible for binding layers 3922 and 3928, includingproviding bondable material attached to the underside of layer 3922, andproviding a separate layer of bondable material between layers 3922 and3928.

FIGS. 78-80 thus illustrate several of the many ways in which methodsand devices of the invention may be used to construct a wide variety ofstructures useful for therapeutic purposes.

It is contemplated that the devices and methods of the present inventionbe applied using minimally invasive incisions and techniques to fasten,for example, muscles, tendons, ligaments, bones, nerves, and bloodvessels. A small incision(s) may be made adjacent the damaged tissuearea to be repaired, and a tube, delivery catheter, sheath, cannula, orexpandable cannula may be used to perform the methods of the presentinvention. In addition to using a cannula with the present invention, anintroducer may be utilized to position implants at a specific locationwithin the body.

The methods of the present invention may further be performed underindirect visualization, such as endoscopic guidance, computer assistednavigation, magnetic resonance imaging, CT scan, ultrasound,fluoroscopy, X-ray, or other suitable visualization technique. Theimplants, fasteners, fastener assemblies, and sutures of the presentinvention may include a radiopaque material for enhancing indirectvisualization. The use of these visualization means along with minimallyinvasive surgery techniques permits physicians to accurately and rapidlyrepair, reconstruct, augment, and secure tissue or an implant within thebody.

All references cited herein are expressly incorporated by reference intheir entirety. In addition, unless mention was made above to thecontrary, it should be noted that all of the accompanying drawings arenot to scale.

There are many different features to the present invention and it iscontemplated that these features may be used together or separately.Thus, the invention should not be limited to any particular combinationof features or to a particular application of the invention. Further, itshould be understood that variations and modifications within the spiritand scope of the invention might occur to those skilled in the art towhich the invention pertains. Accordingly, all expedient modificationsreadily attainable by one versed in the art from the disclosure setforth herein that are within the scope and spirit of the presentinvention are to be included as further embodiments of the presentinvention.

What is claimed is:
 1. A controller for use with a joining device, thecontroller comprising: a processor; and a memory device having encodedthereon computer-readable instructions that are executable by theprocessor to perform functions comprising: detecting a pressure appliedto a horn of the joining device when the horn is pressed against a firstcomponent; determining when the pressure is within a predeterminedpressure range indicating that the pressure is suitable for securing thefirst component to a second component; generating energy when thepressure has remained within the predetermined pressure range for atleast a predetermined duration of time; and applying the energy throughthe horn to the first component to secure the first component to thesecond component.
 2. The controller of claim 1, wherein the functionsperformed by the processor further comprise inhibiting the generation ofenergy when the pressure is outside the predetermined pressure range. 3.The controller of claim 1, wherein the functions performed by theprocessor further comprise: determining when the first component issecured to the second component; and stopping the generation of energyafter determining the first component is secured to the secondcomponent.
 4. The controller of claim 3, wherein said determining whenthe first component is secured to the second component comprisesdetermining when a predetermined amount of energy has been applied tothe first component by the joining device.
 5. The controller of claim 1,wherein the energy generated is vibratory energy.
 6. The controller ofclaim 1, wherein the first component is a first medical device componentand the second component is a second medical device component.
 7. Amethod of operating a joining device, said method comprising: detectinga pressure applied to a horn of the joining device when the horn ispressed against a first component; determining when the pressure iswithin a predetermined pressure range indicating that the pressure issuitable for securing the first component to a second component;generating energy when the pressure has remained within thepredetermined pressure range for at least a predetermined duration oftime; and applying the energy through the horn to the first component tosecure the first component to the second component.
 8. The method ofclaim 7, further comprising inhibiting the generation of energy when thepressure is outside the predetermined pressure range.
 9. The method ofclaim 7, further comprising: determining when the first component issecured to the second component; and stopping the generation of energyafter determining the first component is secured to the secondcomponent.
 10. The method of claim 9, further comprising providing anindication when the first component is secured to the second component.11. The method of claim 9, wherein said determining when the firstcomponent is secured to the second component comprises determining whena predetermined amount of energy has been applied to the first componentby the joining device.
 12. The controller of claim 7, wherein the energygenerated is vibratory energy.
 13. The method of claim 7, wherein thefirst component is a first medical device component and the secondcomponent is a second medical device component.
 14. A system comprising:an applicator configured to generate vibratory energy; and a generatorcoupled to the applicator, the generator comprising a processing deviceand a memory device having encoded thereon computer-readableinstructions that are executable by the processing device to performfunctions comprising: applying a first tuning signal to the applicator,the first tuning signal having a first variable frequency within apredetermined frequency range; detecting a first parameter and a secondparameter of the applicator in response to the first tuning signal;comparing the first parameter and the second parameter to apredetermined parameter range to determine if the detected parametersare outside the predetermined parameter range; and repeating the tuningsignal when the detected parameters are determined to be out of thepredetermined parameter range.
 15. The system of claim 14, wherein thefirst parameter is a first impedance, the second parameter is a secondimpedance, and the predetermined parameter range is a predeterminedimpedance range.
 16. The system of claim 14, further comprising theprocessing device comparing a sensed pressure between the applicator anda surface to a predetermined pressure range to determine if the sensedpressure is within the predetermined pressure range.
 17. The system ofclaim 16, wherein the function of applying the first tuning signal tothe application is inhibited when the pressure is outside thepredetermined pressure range.
 18. The system of claim 16, wherein thegeneration of vibratory energy is inhibited when the pressure is outsidethe predetermined pressure range.
 19. The system of claim 16, whereinthe surface is a surface of a first component, wherein the firstcomponent is configured to be joined to a second component.
 20. Thesystem of claim 19, wherein the first component is a first medicaldevice component and the second component is a second medical devicecomponent.